Identity
- Trade Name
- Austin FDA UDI
- Generic Name
- Patient surgical drape, single-use FDA UDI
- Device Name
- Mother’s Viewing Drape with Bleed ID Window FDA UDI
- Model / Reference
- A-AU-10-122S FDA UDI
- Description
- Mother’s Viewing Drape with Bleed ID Window FDA UDI
Identifiers
- Catalog Number
- A-AU-10-122S FDA UDI
- Primary DI / UDI-DI
- 00850017635418 FDA UDI
- 510(k) Number
- K101598 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
Austin 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
K101598 also covers:
- CCORE — C-CORE MEDICAL, INC.
- CCore — C-CORE MEDICAL, INC.
- Clever Medical — CLEVER MEDICAL, INC.
- Dinamic OR Gerstner Double Wide Blue Cover Labeled B1-B8 — FLEX OPERATING ROOM, INC
- Dinamic OR Gerstner Double Wide Orange Cover Labeled A1-A8 — FLEX OPERATING ROOM, INC
- Dinamic OR Gerstner Triple Wide Orange Cover Labeled A1-A12 — FLEX OPERATING ROOM, INC
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 2350aef8-7254-4a81-8b9b-010663e66165 35 fields · synced May 30, 2026