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Device Explorer · FDA GUDID · GMDN 15155

Inoculating tool IVD, manual

A hand-held device intended to be used to transfer and spread inoculum from a clinical specimen and/or culture isolate into a culture medium (e.g., agar or broth) for subsequent in vitro diagnostic processing and/or testing. It typically consists of a slender

US‑registered devices65in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile85%labelled sterile
Prescription17%Rx‑only share
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Share of device records

Globe Scientific Inc.1929%
Copan Italia Spa1117%
Simport Scientific Inc.914%
Cardinal Health 200, Llc812%
Caplugs812%
Becton, Dickinson And Company58%
Typenex Medical Llc23%
Bp Pharmaceuticals Laboratories Unlimited Company23%

Top labelers

CompanyDevicesShare
Globe Scientific Inc.1929%
Copan Italia Spa1117%
Simport Scientific Inc.914%
Cardinal Health 200, Llc812%
Caplugs812%
Becton, Dickinson And Company58%
Typenex Medical Llc23%
Bp Pharmaceuticals Laboratories Unlimited Company23%
Zhejiang Gongdong Medical Technology Co., Ltd.12%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

GongdongCARDINAL HEALTHGlobe ScientificTypenex Medical Inoculation LoopCaplugs/EvergreenBD Calibrated Disposable Inoculating Loops, BlueBD Calibrated Disposable Inoculating Loops, GreeAmerisourceBergenInoculation LoopsInoculation NeedlesIno-Loop

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

FDA product codes

CodeNameDevices
LIBDevice, General Purpose, Microbiology, Diagnostic20
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted 17
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED 13
LIBDEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC8
JSMCulture Media, Non-Propagating Transport1

GMDN & GCC registration

  • GMDN code 15155 · non‑implantable
  • Single‑use 100% · sterile 85% · Rx‑only 17% · OTC 15%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Total Volume (Microliter) · 6

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

No closely related category with 50+ devices.

How many inoculating tool ivd, manual products are registered in the US?

65 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Inoculating tool IVD, manual", from 9 companies. The largest labeler is Globe Scientific Inc. with 29% of records.

Which FDA product codes apply?

LIB (Device, General Purpose, Microbiology, Diagnostic), LXG (Equipment, Laboratory, General Purpose, Labeled Or Promoted ), LXG (EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED ), LIB (DEVICE, GENERAL PURPOSE, MICROBIOLOGY, DIAGNOSTIC)

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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