Identity
- Trade Name
- Medicom SafeGauze FDA UDI
- Generic Name
- Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial FDA UDI
- Device Name
- SAFEGAUZE HEMOSTAT STERILE - TOPICAL DENTAL DRESSING - 4PLY - 0.75" X 0.75" - WHITE - Sample Pack FDA UDI
- Model / Reference
- SP-4900 FDA UDI
- Description
- SAFEGAUZE HEMOSTAT STERILE - TOPICAL DENTAL DRESSING - 4PLY - 0.75" X 0.75" - WHITE - Sample Pack FDA UDI
Identifiers
- Catalog Number
- SP-4900 FDA UDI
- Primary DI / UDI-DI
- 20686864054683 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
- Not 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
Medicom SafeGauze by AMD Medicom Inc — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K173196 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- AMD Medicom Inc
Sources (1)
- FDA UDI 3a9381fe-873f-4ec4-a811-923b6683432a 39 fields · synced Jun 8, 2026