Consulting Wallah › Device Explorer › Wound care & sutures › Non-woven gauze roll/sheet
Device Explorer · FDA GUDID · GMDN 63661

Non-woven gauze roll/sheet

A device in the form of a long length of stretchable, non-woven material (e.g., rayon/polyester), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury pad

US‑registered devices127in commercial distribution
Companies19labelers on GUDID
Single‑use100%of device records
Sterile37%labelled sterile
Prescription0%Rx‑only share
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Share of device records

Sigvaris Inc4031%
Certified Safety Manufacturing, Inc.3628%
Medline Industries, Inc.1713%
Topco Associates, Llc43%
Resource Optimization & Innovation, L.L.C.43%
Dealmed Medical Supplies Llc32%
Cardinal Health 200, Llc32%
Hans Hepp Gmbh & Co. Kg22%

Top labelers

CompanyDevicesShare
Sigvaris Inc4031%
Certified Safety Manufacturing, Inc.3628%
Medline Industries, Inc.1713%
Topco Associates, Llc43%
Resource Optimization & Innovation, L.L.C.43%
Dealmed Medical Supplies Llc32%
Cardinal Health 200, Llc32%
Hans Hepp Gmbh & Co. Kg22%
Vive Health Llc22%
Aafes22%
Walgreen Co.22%
Cardinal Health 110, Inc.22%

Company = labeler of record on GUDID. 19 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Bandaging Cloth A 600mm x 800mmCuradDealmedRospital Productos MedicosViveCarePackout-11 - Class B First Aid Kit - PolySB2 - City of Richmond36M - Marathon Petroleum LS Terminals - MetalUPRR - Flambeau Trauma16PW - Wisconsin Energy - Poly White24M - Peoples Gas - Metal18M - Huntsville Utilities - Metal75H - Class A Select - 2 Shelf Cabinet36M - Foodmaker Class A - Metal16PW - Class A Blue Metal Detectable - Poly Whit36M - Class A Office - Metal

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

FDA product codes

CodeNameDevices
FQMBandage, Elastic40
FMPProtector, Skin Pressure40
EFQGAUZE/SPONGE, INTERNAL36
LRRFirst Aid Kit with drug33
KGXTape and bandage, adhesive33
CBPValve, non-rebreathing31

GMDN & GCC registration

  • GMDN code 63661 · non‑implantable
  • Single‑use 100% · sterile 37% · Rx‑only 0% · OTC 36%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 10Length (Yard) · 5Width (Centimeter) · 2Length (Inch) · 1

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

How many non-woven gauze roll/sheet products are registered in the US?

127 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-woven gauze roll/sheet", from 19 companies. The largest labeler is Sigvaris Inc with 31% of records.

Which FDA product codes apply?

FQM (Bandage, Elastic), FMP (Protector, Skin Pressure), EFQ (GAUZE/SPONGE, INTERNAL), LRR (First Aid Kit with drug)

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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