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Medicom SafeGauze

FDA UDI

Class U (US FDA UDI)

by AMD Medicom Inc

Identity

Trade Name
Medicom SafeGauze FDA UDI
Generic Name
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI
Device Name
Medicom SafeGauze HemoStat - Topical Dental Dressing - Sterile - 4 Ply - White 0.75" x 0.75" FDA UDI
Model / Reference
4900-STAT FDA UDI
Description
Medicom SafeGauze HemoStat - Topical Dental Dressing - Sterile - 4 Ply - White 0.75" x 0.75" FDA UDI

Identifiers

Catalog Number
4900-STAT FDA UDI
Primary DI / UDI-DI
10686864055089 FDA UDI
510(k) Number
K173196 FDA UDI
FDA Product Code
MGQ FDA UDI
GMDN Term
Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI

Classification

Device Class
U FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial

Medicom SafeGauze by AMD Medicom Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial.

Cleared under the same submission

K173196 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
AMD Medicom Inc

Sources (1)

  • FDA UDI 3b3c4d94-eecf-41cf-8155-0f526ae761c4 38 fields · synced May 30, 2026