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Device Explorer · FDA GUDID · GMDN 61634

Sharp surgical instrument counting tray/pad, single-use

A device intended to be used in the operating room (OR) by staff to maintain the count of various sharp surgical instruments (e.g., needles, blades, scissors) to prevent instruments from being inadvertently left in a patient; it may in addition be used for tem

US‑registered devices434in commercial distribution
Companies12labelers on GUDID
Single‑use100%of device records
Sterile43%labelled sterile
Prescription23%Rx‑only share
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Share of device records

Xodus Medical, Inc.14734%
Deroyal Industries, Inc.9722%
Medical Action Industries Inc.7016%
Gri Medical & Electronic Technology Co., Ltd.6014%
Cardinal Health 200, Llc4310%
Newgen Surgical, Inc.72%
Key Surgical, Inc.41%
Aspen Surgical Products, Inc.20%

Top labelers

CompanyDevicesShare
Xodus Medical, Inc.14734%
Deroyal Industries, Inc.9722%
Medical Action Industries Inc.7016%
Gri Medical & Electronic Technology Co., Ltd.6014%
Cardinal Health 200, Llc4310%
Newgen Surgical, Inc.72%
Key Surgical, Inc.41%
Aspen Surgical Products, Inc.20%
Custom Assemblies, Inc.10%
Resource Optimization & Innovation, L.L.C.10%
Owens & Minor Distribution, Inc.10%
Medline Industries, Inc.10%

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

Brand names on the register (sample)

DevonCARDINAL HEALTHKey Surgical Needle CountersScalpel Blade Remover, SterileScalpel Blade Remover, Non-SterileCustom Medical Specialties, Inc.NP673CASE 10 Count Foam BlockNS80200 Syringe Transfer Tray with Blue Foam BloNS80100 Syringe Transfer CupNS70961 Double magnet w/out #'s large- 60 count NS70960 Needle Counter Double Blank Magnet LargeNS70931 Needle Counter Double Blank Magnet SmallNS70930 Needle Counter Double Blank Magnet SmallNS70900Y Yellow Needle Counter Double 30 Ct Mag NS70900 Needle Counter Double 30 Count Magnet 60NS70890Y Yellow Needle Counter Double Magnet 30-

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

FDA product codes

CodeNameDevices
GABNEEDLE, SUTURING, DISPOSABLE170
FSMTRAY, SURGICAL, INSTRUMENT137
KDCINSTRUMENT, SURGICAL, DISPOSABLE95
GABNeedle, Suturing, Disposable48
HXKHolder, Needle; Orthopedic5
KDCInstrument, Surgical, Disposable4

GMDN & GCC registration

  • GMDN code 61634 · non‑implantable
  • Single‑use 100% · sterile 43% · Rx‑only 23% · OTC 26%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

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

No closely related category with 50+ devices.

How many sharp surgical instrument counting tray/pad, single-use products are registered in the US?

434 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Sharp surgical instrument counting tray/pad, single-use", from 12 companies. The largest labeler is Xodus Medical, Inc. with 34% of records.

Which FDA product codes apply?

GAB (NEEDLE, SUTURING, DISPOSABLE), FSM (TRAY, SURGICAL, INSTRUMENT), KDC (INSTRUMENT, SURGICAL, DISPOSABLE), GAB (Needle, Suturing, Disposable)

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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