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Device Explorer · FDA GUDID · GMDN 47821

Surgical retractor/retraction system blade, single-use

A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge/hook to separate the margins of a wound/incision during a surgical procedure. It is intended to be attac

US‑registered devices272in commercial distribution
Companies15labelers on GUDID
Single‑use89%of device records
Sterile58%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Applied Medical Technology, Inc.5119%
Amplify Surgical, Inc.4416%
Alphatec Spine, Inc.3814%
Evonos Gmbh & Co. Kg3312%
Astura Medical2710%
Coopersurgical, Inc.2610%
Mosaic Surgical Limited156%
Endosys Healthcare India Private Limited156%

Top labelers

CompanyDevicesShare
Applied Medical Technology, Inc.5119%
Amplify Surgical, Inc.4416%
Alphatec Spine, Inc.3814%
Evonos Gmbh & Co. Kg3312%
Astura Medical2710%
Coopersurgical, Inc.2610%
Mosaic Surgical Limited156%
Endosys Healthcare India Private Limited156%
Scanlan International Inc52%
Lina Medical Ag41%
Lina Medical Aps41%
Med Michigan Holdings, Llc31%

Company = labeler of record on GUDID. 15 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LiNA Skin Hook™evonosLone StarSCANLAN® M.D.™ Sternal Retractor SystemTLC Self-Retaining Retractor SystemTLC® Retractor (Wilson Penile Implantation SysteTLC Retractor StaysTLC Self-Retaining Retractor System (Wilson ScroTLC Self-Retaining Retractor StaysTLC Support StrapGeneral InstrumentsEL CAPITANSurge CardiovascularSigmaLIF-PTPDUALX DUAL PORTAL CANNULA 100MM

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

FDA product codes

CodeNameDevices
GADRetractor157
MAXIntervertebral Fusion Device With Bone Graft, Lumbar44
GADRETRACTOR41
LXHOrthopedic Manual Surgical Instrument27
KALRetractor, Ent15
HDLRetractor, Vaginal15

GMDN & GCC registration

  • GMDN code 47821 · non‑implantable
  • Single‑use 89% · sterile 58% · Rx‑only 82% · 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

Tip Bend Radius (Millimeter) · 15Length (Millimeter) · 7Width (Millimeter) · 7Outer Diameter (Centimeter) · 2

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

How many surgical retractor/retraction system blade, single-use products are registered in the US?

272 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical retractor/retraction system blade, single-use", from 15 companies. The largest labeler is Applied Medical Technology, Inc. with 19% of records.

Which FDA product codes apply?

GAD (Retractor), MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), GAD (RETRACTOR), LXH (Orthopedic Manual Surgical Instrument)

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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