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Device Explorer · FDA GUDID · GMDN 47991

Self-retaining surgical retractor, single-use

A sterile, 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 dedicate

US‑registered devices139in commercial distribution
Companies18labelers on GUDID
Single‑use90%of device records
Sterile47%labelled sterile
Prescription85%Rx‑only share
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Share of device records

Novo Surgical, Inc.4230%
Neo Medical Sa2216%
Sklar Corporation1612%
Biopro, Inc.1410%
Surgical Principals, Inc86%
Coopersurgical, Inc.64%
Medtronic Navigation, Inc.64%
Aesculap Ag43%

Top labelers

CompanyDevicesShare
Novo Surgical, Inc.4230%
Neo Medical Sa2216%
Sklar Corporation1612%
Biopro, Inc.1410%
Surgical Principals, Inc86%
Coopersurgical, Inc.64%
Medtronic Navigation, Inc.64%
Aesculap Ag43%
Teleflex Incorporated43%
Med Saver, Inc.43%
Covidien Lp43%
Medacta International Sa32%

Company = labeler of record on GUDID. 18 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VersiQuadRetractor West Self Retaining (Sharp)VALVE XSSUSISHAMROCKFLEXWECKGuardian VAGINAL RETRACTOR™Mobius Elastic RetractorWatson Flex Retractor SystemMaxRetractNovo Surgical IncNovo Surgical Inc.NICO SecureHoldRadiaLux™MSI Precision Specialty InstrumentsRETRACTOR

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

FDA product codes

CodeNameDevices
KALRetractor, Ent42
GADRetractor39
GADRETRACTOR21
HWNInstrument, Compression14
FFORETRACTOR, SELF-RETAINING13
HAOINSTRUMENT, SURGICAL, NON-POWERED4

GMDN & GCC registration

  • GMDN code 47991 · non‑implantable
  • Single‑use 90% · sterile 47% · Rx‑only 85% · 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 (Millimeter) · 13Outer Diameter (Millimeter) · 5Length (Inch) · 4Width (Inch) · 4

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

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

139 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Self-retaining surgical retractor, single-use", from 18 companies. The largest labeler is Novo Surgical, Inc. with 30% of records.

Which FDA product codes apply?

KAL (Retractor, Ent), GAD (Retractor), GAD (RETRACTOR), HWN (Instrument, Compression)

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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