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Device Explorer · FDA GUDID · GMDN 45182

Self-retaining surgical retractor, reusable

A hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to opht

US‑registered devices11,819in commercial distribution
Companies109labelers on GUDID
Single‑use1%of device records
Sterile0%labelled sterile
Prescription54%Rx‑only share
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Share of device records

Surgical Direct, Inc.2,57822%
Avalign Technologies, Inc.1,63414%
Koros U.S.A., Inc.6085%
Surtex Instruments Ltd.5845%
Medicon Eg. Chirurgiemechaniker-Genossenschaft5555%
Aesculap Ag5284%
Boss Instruments, Ltd., Inc.3573%
Integra Lifesciences Production Corporation3243%

Top labelers

CompanyDevicesShare
Surgical Direct, Inc.2,57822%
Avalign Technologies, Inc.1,63414%
Koros U.S.A., Inc.6085%
Surtex Instruments Ltd.5845%
Medicon Eg. Chirurgiemechaniker-Genossenschaft5555%
Aesculap Ag5284%
Boss Instruments, Ltd., Inc.3573%
Integra Lifesciences Production Corporation3243%
Life Instrument Corporation3213%
Teleflex Incorporated3023%
Aspen Surgical Products, Inc.2682%
Highridge Medical, Llc2072%

Company = labeler of record on GUDID. 109 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Specialty DSA Retractor PinINSTRUMENTSellors - Nut & Bolt (Pair)Sellors Retractor Large Blade (Pair)Sellors Retractor Medium Blade (Pair)Sellors Retractor Small Blade (Pair)Sellors KeyStifle Distractor, 15Kg and Above, 145mm O/L, 45SPAIRE Offset Hip Retractor, Self Retaining, OddSPAIRE Offset Hip Retractor, Self Retaining, OddKolbel Retractor, complete with 3 sets of bladesCharnley Initial Incision Retractor Extra Long BCharnley Initial Incision Retractor- Frame OnlyCharnley Initial Incision Retractor Blades, StanNorfolk & Norwich Retractor, Long Teeth, 4x5 BluCharnley Initial Incision Retractor Long Blades

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
GADRETRACTOR2,850
GADRetractor2,437
FFORETRACTOR, SELF-RETAINING2,382
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY1,567
LXHOrthopedic manual surgical instrument722
GZTRetractor, Self-Retaining, For Neurosurgery517

GMDN & GCC registration

  • GMDN code 45182 · non‑implantable
  • Single‑use 1% · sterile 0% · Rx‑only 54% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 608Length (Millimeter) · 311Width (Millimeter) · 259Length (Centimeter) · 161Width (Inch) · 114Depth (Millimeter) · 73

Use these as the dimensions to specify in a tender line.

How many self-retaining surgical retractor, reusable products are registered in the US?

11,819 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Self-retaining surgical retractor, reusable", from 109 companies. The largest labeler is Surgical Direct, Inc. with 22% of records.

Which FDA product codes apply?

GAD (RETRACTOR), GAD (Retractor), FFO (RETRACTOR, SELF-RETAINING), GZT (RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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