Consulting Wallah › Device Explorer › Other devices › Surgical retraction system mounting frame, reusabl
Device Explorer · FDA GUDID · GMDN 35967

Surgical retraction system mounting frame, reusable

A noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to

US‑registered devices1,375in commercial distribution
Companies35labelers on GUDID
Single‑use2%of device records
Sterile2%labelled sterile
Prescription88%Rx‑only share
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Share of device records

Geister Medizintechnik Gmbh55040%
Hayden Medical, Inc.13210%
Boss Instruments, Ltd., Inc.826%
Avalign Technologies, Inc.745%
Aspen Surgical Products, Inc.725%
Flexbar Machine Corporation655%
Aesculap Ag564%
Vb Spine Llc363%

Top labelers

CompanyDevicesShare
Geister Medizintechnik Gmbh55040%
Hayden Medical, Inc.13210%
Boss Instruments, Ltd., Inc.826%
Avalign Technologies, Inc.745%
Aspen Surgical Products, Inc.725%
Flexbar Machine Corporation655%
Aesculap Ag564%
Vb Spine Llc363%
Synthes Gmbh292%
Surgipros, Llc252%
Surgical Direct, Inc.252%
Applied Medical Technology, Inc.242%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ARIA SPINAL SYSTEMARIAES2 SPINAL SYSTEMLUXORLITe PEDICLE BASED RETRACTORApplicator brush (endo<black>)Trinity Acetabular Hip SystemRenal vein blade 25x120 - 1,5mm for BluCLASCircular frame Ø240 with serrated washer for BluFlexible illumination terminal with universal coRenal vein blade 25x160 - 2mm for BluCLASRenal vein blade 25x120 - 2mm for BluCLASRenal vein blade 25x80 - 2mm for BluCLASTwo-sided angling blade holder for BluCLASBlade holder - 2mm for BluCLASUniversal Clamp for BluCLAS

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

FDA product codes

CodeNameDevices
GZTRETRACTOR, SELF-RETAINING, FOR NEUROSURGERY715
GADRetractor178
FFORETRACTOR, SELF-RETAINING176
GADRETRACTOR131
FFORetractor, Self-Retaining68
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT56

GMDN & GCC registration

  • GMDN code 35967 · non‑implantable
  • Single‑use 2% · sterile 2% · Rx‑only 88% · 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) · 48Length (Millimeter) · 24Width (Inch) · 21Outer Diameter (Centimeter) · 7Width (Millimeter) · 7Outer Diameter (Inch) · 6

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

How many surgical retraction system mounting frame, reusable products are registered in the US?

1,375 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical retraction system mounting frame, reusable", from 35 companies. The largest labeler is Geister Medizintechnik Gmbh with 40% of records.

Which FDA product codes apply?

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

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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