Identity
- Trade Name
- Clear Horizon FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- "24"" x 24"" SMS Eye Drape w/ 1 fluid control pouch & 4"" x 5"" w/ Incise" FDA UDI
- Model / Reference
- AU-1008S FDA UDI
- Description
- "24"" x 24"" SMS Eye Drape w/ 1 fluid control pouch & 4"" x 5"" w/ Incise" FDA UDI
Identifiers
- Catalog Number
- AU-1008S FDA UDI
- Primary DI / UDI-DI
- 00866001000322 FDA UDI
- 510(k) Number
- K061422 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Patient surgical drape, single-use 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
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
Yes
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: Patient surgical drape, single-use
Clear Horizon by Austin Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K061422 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 II | Pending data |
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Manufacturer
- Manufacturer
- Austin Medical, Inc.
Sources (1)
- FDA UDI 8f1f3aff-fb53-46da-bc2d-5af1e41fcf0f 36 fields · synced May 30, 2026