Identity
- Trade Name
- AngioSystems Drape FDA UDI
- Generic Name
- General surgical procedure kit, medicated FDA UDI
- Model / Reference
- 5061 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816611022924 FDA UDI
- 510(k) Number
- K905462 FDA UDI
- FDA Product Code
- LRP FDA UDI
- GMDN Term
- General surgical procedure kit, medicated FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
No
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: General surgical procedure kit, medicated
AngioSystems Drape by Angiosystems, Incorporated — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K905462 also covers:
- AngioSystems Cap Cover — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Cap Cover — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Tray — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Tray — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Tray — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Tray — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Tray — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Tray — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Tray — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Tray — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Tray — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Tray — ANGIOSYSTEMS, INCORPORATED
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 I | Pending data |
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Manufacturer
- Manufacturer
- Angiosystems, Incorporated
Sources (1)
- FDA UDI c329f3d4-206d-4af1-ac6d-fe8a6cad758f 33 fields · synced May 31, 2026