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Device Explorer · FDA GUDID · GMDN 63406

Device operating status label/tag, single-use

A label or a tag intended to indicate/collect the operating status of a device to which it is attached; it does not include any additional functionality and does not include a sterilization process indicator. It is typically constructed from a durable material

US‑registered devices318in commercial distribution
Companies10labelers on GUDID
Single‑use76%of device records
Sterile0%labelled sterile
Prescription30%Rx‑only share
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Share of device records

Batrik Medical Manufacturing Inc16652%
Sontec Instruments, Inc.7423%
Aspen Surgical Products, Inc.309%
Cygnus Medical L.L.C.248%
Steris Corporation103%
Ashland Specialty Ingredients G.P.62%
Case Medical Inc.52%
Landanger10%

Top labelers

CompanyDevicesShare
Batrik Medical Manufacturing Inc16652%
Sontec Instruments, Inc.7423%
Aspen Surgical Products, Inc.309%
Cygnus Medical L.L.C.248%
Steris Corporation103%
Ashland Specialty Ingredients G.P.62%
Case Medical Inc.52%
Landanger10%
Bioseal10%
Sakura Finetek U.S.A., Inc.10%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

LANDANGERCYGNUS"SingleCycle Biohazard Self-Sealing label 25"" ""SingleCycle Biohazard Self-Sealing label 15"" "Surface Disinfection Verification Label Pad - ReRemovable Low-Tack Clean LabelRemovable Low-Tack Biohazard LabelRemovable Low-Tack Double-Layer Biohazard / Clea"""BIOHAZARD/SOILED INSTRUMENTS"" tamper-proof l"""INSTRUMENTS READY FOR USE"" tamper-proof labeRemovable High Level Disinfected (HLD) LabelDaily Countdown Scope Tag - Combo, pressure-sensDaily Countdown Scope Tag - Sunday, pressure-senDaily Countdown Scope Tag - Saturday, pressure-sDaily Countdown Scope Tag - Friday, pressure-senDaily Countdown Scope Tag - Thursday, pressure-s

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

FDA product codes

CodeNameDevices
MDMInstrument, Manual, Surgical, General Use165
LYVLABEL OR TAG, STERILE75
LYVLabel Or Tag, Sterile32
KSSSupplies, Blood-Bank20
PXVGeneral Purpose Instrument Tray12
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE10

GMDN & GCC registration

  • GMDN code 63406 · non‑implantable
  • Single‑use 76% · sterile 0% · Rx‑only 30% · OTC 5%
  • 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.

How many device operating status label/tag, single-use products are registered in the US?

318 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Device operating status label/tag, single-use", from 10 companies. The largest labeler is Batrik Medical Manufacturing Inc with 52% of records.

Which FDA product codes apply?

MDM (Instrument, Manual, Surgical, General Use), LYV (LABEL OR TAG, STERILE), LYV (Label Or Tag, Sterile), KSS (Supplies, Blood-Bank)

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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