Consulting Wallah › Device Explorer › Other devices › Non-organic haemostatic agent
Device Explorer · FDA GUDID · GMDN 47917

Non-organic haemostatic agent

A non-bioabsorbable device made of mineral and/or synthetic polymer components (e.g., smectite, potassium ferrate/hydrophilic polymer) intended for application to a bleeding external epithelial wound [i.e., skin wound or gastrointestinal (GI) mucosa wound] to

US‑registered devices282in commercial distribution
Companies9labelers on GUDID
Single‑use100%of device records
Sterile96%labelled sterile
Prescription62%Rx‑only share
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Share of device records

Teleflex Incorporated9634%
Adventure Ready Brands5319%
Z-Medica, Llc4717%
Wuxi Emsrun Technology Co., Ltd.4115%
Biolife, L.L.C.3512%
Hangzhou Zeo-Innov Life Technology Co., Ltd.31%
Nextbiomedical Co., Ltd.31%
3-D Matrix Inc.21%

Top labelers

CompanyDevicesShare
Teleflex Incorporated9634%
Adventure Ready Brands5319%
Z-Medica, Llc4717%
Wuxi Emsrun Technology Co., Ltd.4115%
Biolife, L.L.C.3512%
Hangzhou Zeo-Innov Life Technology Co., Ltd.31%
Nextbiomedical Co., Ltd.31%
3-D Matrix Inc.21%
Cook Incorporated21%

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

Brand names on the register (sample)

RHINO RESCUERhino RescueLightning X Products,IncEMSRUNQuiCoverPuraStat (3mL)PuraStat (1mL)QuikClotStatSeal®WoundSeal®HemosprayAdventure Medical KitsQUIKCLOTNexpowder

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

FDA product codes

CodeNameDevices
FRODressing, Wound, Drug98
QSYHemostatic wound dressing without thrombin or other biologic58
NADDressing, Wound, Occlusive41
QSYHemostatic Wound Dressing Without Thrombin Or Other Biologic38
PODTemporary, internal use hemostatic28
FRODressing, wound, drug10

GMDN & GCC registration

  • GMDN code 47917 · non‑implantable
  • Single‑use 100% · sterile 96% · Rx‑only 62% · OTC 31%
  • 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 (Centimeter) · 16Length (Centimeter) · 3Width (Centimeter) · 3Weight (Gram) · 1

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

How many non-organic haemostatic agent products are registered in the US?

282 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Non-organic haemostatic agent", from 9 companies. The largest labeler is Teleflex Incorporated with 34% of records.

Which FDA product codes apply?

FRO (Dressing, Wound, Drug), QSY (Hemostatic wound dressing without thrombin or other biologic), NAD (Dressing, Wound, Occlusive), QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologic)

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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