Device Explorer · FDA GUDID · GMDN 15047

Gauze packer

A hand-held, surgical instrument used for introducing and packing gauze or dressings into body cavities. This is a reusable device.

US‑registered devices66in commercial distribution
Companies14labelers on GUDID
Single‑use26%of device records
Sterile26%labelled sterile
Prescription47%Rx‑only share
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Share of device records

Bioseal1726%
Peter Brasseler Holdings, Llc1218%
W.H. Holden, Inc.1015%
Devemed Gmbh69%
Zoll-Dental46%
Aesculap Ag35%
Ace Surgical Supply Co., Inc.35%
Hu-Friedy Mfg. Co., Llc35%

Top labelers

CompanyDevicesShare
Bioseal1726%
Peter Brasseler Holdings, Llc1218%
W.H. Holden, Inc.1015%
Devemed Gmbh69%
Zoll-Dental46%
Aesculap Ag35%
Ace Surgical Supply Co., Inc.35%
Hu-Friedy Mfg. Co., Llc35%
Storz Am Mark Gmbh35%
Medicon Eg. Chirurgiemechaniker-Genossenschaft12%
Boss Instruments, Ltd., Inc.12%
American Eagle Instruments, Inc.12%

Company = labeler of record on GUDID. 14 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ReicodentdevemedMediconAESCULAPBOSS InstrumentsBrasseler USAGAUZE PACKER & LIGATURE DIRECTOR D/E 2.6mm CURVGAUZE PACKER & LIGATURE DIRECTOR D/E 2.0mm CURVGZE PCKR&LIG DIR-D/E 2.6mm HFGAUZE PACKER & LIGATURE DIRECTOR D/E 2.6mmLIGATURE DIRECTOR, S/E HFGAUZE PACKER & LIGATURE DIRECTOR D/E 3.0 mm STRGAUZE PACKER & LIGATURE DIRECTOR D/E 3.0 mmGAUZE PACKER & LIGATURE DIRECTOR D/E 2.5 mmGAUZE PACKER & LIGATURE DIRECTOR D/E 2.0mm HDGAUZE PACKER & LIGATURE DIRECTOR D/E 2.0mm

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

FDA product codes

CodeNameDevices
GDYGauze/sponge, internal, x-ray detectable17
EMDHEMOSTAT, SURGICAL12
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE10
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE8
LXHOrthopedic Manual Surgical Instrument7
DZNINSTRUMENTS, DENTAL HAND6

GMDN & GCC registration

  • GMDN code 15047 · non‑implantable
  • Single‑use 26% · sterile 26% · Rx‑only 47% · 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

Length (Inch) · 3

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

How many gauze packer products are registered in the US?

66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Gauze packer", from 14 companies. The largest labeler is Bioseal with 26% of records.

Which FDA product codes apply?

GDY (Gauze/sponge, internal, x-ray detectable), EMD (HEMOSTAT, SURGICAL), EKG (CONDENSER, AMALGAM AND FOIL, OPERATIVE), 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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