Identity
- Trade Name
- AngioSystems SorbX FDA UDI
- Generic Name
- Patient surgical drape, single-use, non-sterile FDA UDI
- Model / Reference
- SX8330NS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816611024966 FDA UDI
- 510(k) Number
- K843260 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Patient surgical drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Ethylene Oxide FDA UDI
Category: Patient surgical drape, single-use, non-sterile
AngioSystems SorbX by Angiosystems, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K843260 also covers:
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — ANGIOSYSTEMS, INCORPORATED
- AngioSystems Drape — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Angiosystems, Incorporated
Sources (1)
- FDA UDI 4ddff5cd-72b2-481a-9ed9-ebfd0af68644 33 fields · synced Jun 1, 2026