Consulting Wallah › Device Explorer › Other devices › Surgical cutting/shaping board, reusable
Device Explorer · FDA GUDID · GMDN 58387

Surgical cutting/shaping board, reusable

A stiff, plastic device intended to be used as a surface to trim/contour objects or tissues (e.g., implants, transplants) in an operating room (OR) or other clean room during a surgical procedure. It may be flat or contoured and/or have measurement graduations

US‑registered devices54in commercial distribution
Companies18labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription69%Rx‑only share
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Share of device records

Sontec Instruments, Inc.1019%
Marina Medical Instruments, Inc.713%
Spiggle & Theis Medizintechnik Gmbh611%
Avalign Technologies, Inc.59%
Ambler Surgical Corp.47%
Med Saver, Inc.36%
Surgical Direct, Inc.36%
Fentex Medical Gmbh24%

Top labelers

CompanyDevicesShare
Sontec Instruments, Inc.1019%
Marina Medical Instruments, Inc.713%
Spiggle & Theis Medizintechnik Gmbh611%
Avalign Technologies, Inc.59%
Ambler Surgical Corp.47%
Med Saver, Inc.36%
Surgical Direct, Inc.36%
Fentex Medical Gmbh24%
Evonos Gmbh & Co. Kg24%
Br Surgical, Llc24%
Gyrus Acmi, Llc24%
Steris Corporation24%

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

Brand names on the register (sample)

Cutting blockPiston cutting jigFisch cutting and preparation jigFENTEXPreparation tray, stainless steelCutting block, glassevonosAESCULAPSymmetry TeflonHayden MedicalMarina MedicalBR Surgical, LLCGyrus ACMIGraft Processing BoardBausch + LombTissue-Tek® Accu-Edge®

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

FDA product codes

CodeNameDevices
NNRBLOCK, CUTTING, ENT, NON-STERILE24
FZXGuide, surgical, instrument19
HTZINSTRUMENT, CUTTING, ORTHOPEDIC12
NNRBlock, Cutting, Ent, Non-Sterile8
LXHOrthopedic Manual Surgical Instrument5
LRCINSTRUMENT, ENT MANUAL SURGICAL4

GMDN & GCC registration

  • GMDN code 58387 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 69% · 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) · 7Height (Millimeter) · 7Length (Millimeter) · 7Length (Inch) · 1Width (Inch) · 1

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

How many surgical cutting/shaping board, reusable products are registered in the US?

54 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical cutting/shaping board, reusable", from 18 companies. The largest labeler is Sontec Instruments, Inc. with 19% of records.

Which FDA product codes apply?

NNR (BLOCK, CUTTING, ENT, NON-STERILE), FZX (Guide, surgical, instrument), HTZ (INSTRUMENT, CUTTING, ORTHOPEDIC), NNR (Block, Cutting, Ent, Non-Sterile)

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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