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Device Explorer · FDA GUDID · GMDN 47825

Surgical instrument track identification tape

A non-sterile, colour-coded, band coated on one side with a pressure-sensitive adhesive intended to attach to a surgical instrument; it is typically wrapped around the handle or shaft to indicate instrument ownership (e.g., by doctor, hospital floor, departmen

US‑registered devices526in commercial distribution
Companies15labelers on GUDID
Single‑use73%of device records
Sterile0%labelled sterile
Prescription6%Rx‑only share
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Share of device records

Scanlan International Inc18435%
Aspen Surgical Products, Inc.13125%
Batrik Medical Manufacturing Inc6212%
Pulpdent Corporation316%
Henry Schein, Inc.275%
Polydentia Sa224%
Sklar Corporation173%
Novo Surgical, Inc.173%

Top labelers

CompanyDevicesShare
Scanlan International Inc18435%
Aspen Surgical Products, Inc.13125%
Batrik Medical Manufacturing Inc6212%
Pulpdent Corporation316%
Henry Schein, Inc.275%
Polydentia Sa224%
Sklar Corporation173%
Novo Surgical, Inc.173%
Katena Products, Inc.122%
Frontier Dental Supply Inc71%
Jmu Dental, Inc51%
Medline Industries, Inc.51%

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

Brand names on the register (sample)

Trinity Acetabular Hip System with HXLPE Linersmaxi id-ringsid-ringsScanlan® SURG-I-BAND® Color Coding - Data MatrixScanlan® SURG-I-BAND® color codingScanlan® SURG-I-BAND® Color Coding - System acceGen. Acces/ Instr. Tip GuardJMUBR Surgical, LLCColorTrack® Identification Sheet TapeColorTrack® STRIPED Identification Sheet TapeColorTrack® Roll TapeColorTrack® Instrument Id Roll TapeColorTrack® Hearts Identification Sheet TapeColorTrack® Identification Sheet TapeColorTrack® Identification Roll Tape

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

FDA product codes

CodeNameDevices
FWZOperating Room Accessories Table Tray196
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE179
LYVLabel Or Tag, Sterile91
MDMInstrument, Manual, Surgical, General Use87
EBLPin, Retentive And Splinting, And Accessory Instruments31
DZNInstruments, Dental Hand22

GMDN & GCC registration

  • GMDN code 47825 · non‑implantable
  • Single‑use 73% · sterile 0% · Rx‑only 6% · OTC 4%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Outer Diameter (Millimeter) · 43Lumen/Inner Diameter (Millimeter) · 42Length (Centimeter) · 34Lumen/Inner Diameter (Micrometer) · 1

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

How many surgical instrument track identification tape products are registered in the US?

526 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Surgical instrument track identification tape", from 15 companies. The largest labeler is Scanlan International Inc with 35% of records.

Which FDA product codes apply?

FWZ (Operating Room Accessories Table Tray), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), LYV (Label Or Tag, Sterile), MDM (Instrument, Manual, Surgical, General Use)

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.

How do I get quotes?

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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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