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Device Explorer · FDA GUDID · GMDN 35335

Dura mater dissector

A hand-held surgical instrument, usually softly rounded and curved at the working end, used to separate the outermost membrane covering of the brain and spinal cord from the inner membranes. It is usually designed with a handle which continues into a shaft tha

US‑registered devices152in commercial distribution
Companies15labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription84%Rx‑only share
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Share of device records

Integra Lifesciences Production Corporation7650%
Avalign Technologies, Inc.1611%
Sklar Corporation107%
Novo Surgical, Inc.107%
Kls-Martin L.P.85%
Teleflex Incorporated85%
Hayden Medical, Inc.64%
Gsource Llc43%

Top labelers

CompanyDevicesShare
Integra Lifesciences Production Corporation7650%
Avalign Technologies, Inc.1611%
Sklar Corporation107%
Novo Surgical, Inc.107%
Kls-Martin L.P.85%
Teleflex Incorporated85%
Hayden Medical, Inc.64%
Gsource Llc43%
Adler, Inc.43%
Raw Surgical Corporation43%
Elite Medical Instrumentation21%
Mizuho Corporation11%

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

Brand names on the register (sample)

Dural ElevatorHermann Medizintechnik GmbHDISSECTORSPREADERHayden MedicalgSourceAdler Instrument CompanyMillenniumAvalignAmbler SurgicalSurgical DirectPILLINGSklarSklar®Integra® Miltex®Integra® Ruggles®-Redmond™

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-POWERED88
GZXINSTRUMENT, MICROSURGICAL27
HAOInstrument, Surgical, Non-Powered15
KBMDISSECTOR, TONSIL10
GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY6
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY4

GMDN & GCC registration

  • GMDN code 35335 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 84% · 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) · 12Angle (degree) · 6Length (Inch) · 6Length (Millimeter) · 4Outer Diameter (Millimeter) · 3

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

How many dura mater dissector products are registered in the US?

152 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dura mater dissector", from 15 companies. The largest labeler is Integra Lifesciences Production Corporation with 50% of records.

Which FDA product codes apply?

HAO (INSTRUMENT, SURGICAL, NON-POWERED), GZX (INSTRUMENT, MICROSURGICAL), HAO (Instrument, Surgical, Non-Powered), KBM (DISSECTOR, TONSIL)

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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