Device Explorer · FDA GUDID · GMDN 35343

Brain spatula

A hand-held manual surgical instrument designed to manipulate neural tissue or to remove a material from a neural surface or vessel during brain surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a broad flat bl

US‑registered devices463in commercial distribution
Companies22labelers on GUDID
Single‑use1%of device records
Sterile1%labelled sterile
Prescription82%Rx‑only share
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Share of device records

Ambler Surgical Corp.5512%
Integra Lifesciences Production Corporation5011%
Avalign Technologies, Inc.4410%
Peter Lazic Gmbh337%
Steris Corporation317%
Aesculap Ag306%
Boss Instruments, Ltd., Inc.286%
Sklar Corporation255%

Top labelers

CompanyDevicesShare
Ambler Surgical Corp.5512%
Integra Lifesciences Production Corporation5011%
Avalign Technologies, Inc.4410%
Peter Lazic Gmbh337%
Steris Corporation317%
Aesculap Ag306%
Boss Instruments, Ltd., Inc.286%
Sklar Corporation255%
Tedan Surgical Innovations, L.L.C.225%
Aspen Surgical Products, Inc.215%
Aesculap, Inc.184%
Medicon Eg. Chirurgiemechaniker-Genossenschaft153%

Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LAZICn.a.AESCULAPNOIRMediconBOSS InstrumentsRETRACTORSPATULASymmetry DavisSymmetry HirschmanSymmetry CullerSymmetry KimuraSymmetry CastroviejoSymmetry ElschnigSymmetry RaininSymmetry Surgical

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

FDA product codes

CodeNameDevices
HAOINSTRUMENT, SURGICAL, NON-POWERED235
GAFSPATULA, SURGICAL, GENERAL & PLASTIC SURGERY73
GAFSpatula, Surgical, General & Plastic Surgery68
GZTRetractor, Self-Retaining, For Neurosurgery31
HAOInstrument, Surgical, Non-Powered29
GEGELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY15

GMDN & GCC registration

  • GMDN code 35343 · non‑implantable
  • Single‑use 1% · sterile 1% · 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

Width (Millimeter) · 30Length (Inch) · 18Width (Inch) · 10Length (Centimeter) · 6Depth (Millimeter) · 5Length (Millimeter) · 4

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

How many brain spatula products are registered in the US?

463 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Brain spatula", from 22 companies. The largest labeler is Ambler Surgical Corp. with 12% of records.

Which FDA product codes apply?

HAO (INSTRUMENT, SURGICAL, NON-POWERED), GAF (SPATULA, SURGICAL, GENERAL & PLASTIC SURGERY), GAF (Spatula, Surgical, General & Plastic Surgery), 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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