Identity
- Trade Name
- Cassette Drape FDA UDI
- Generic Name
- Medical equipment handle cover, single-use FDA UDI
- Device Name
- Disposable Equipment Cover FDA UDI
- Model / Reference
- CD05NS FDA UDI
- Description
- Disposable Equipment Cover FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848340016172 FDA UDI
- 510(k) Number
- K850959 FDA UDI
- FDA Product Code
- JAA FDA UDI
- GMDN Term
- Medical equipment handle cover, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical equipment handle cover, single-use
Cassette Drape by Advance Medical Designs, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Medical equipment handle cover, single-use.
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- Disposable Handle Polaris, Single — Drägerwerk AG & Co. KGaA · Class II
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Cleared under the same submission
K850959 also covers:
- 9600/9800/9900 C-Arm Consu. — Advance Medical Designs, Inc.
- Arm Drape — Advance Medical Designs, Inc.
- Cable Sleeve — Advance Medical Designs, Inc.
- Camera Cover — Advance Medical Designs, Inc.
- Camera Drape — Advance Medical Designs, Inc.
- Camera Drape — Advance Medical Designs, Inc.
- Camera Drape — Advance Medical Designs, Inc.
- Cassette Drape — Advance Medical Designs, Inc.
- Cassette Drape — Advance Medical Designs, Inc.
- Celfina Cover Motor Module — Advance Medical Designs, Inc.
- Custom Bag W/Cuff — Advance Medical Designs, Inc.
- Custom Cover — Advance Medical Designs, 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
- Advance Medical Designs, Inc.
Sources (1)
- FDA UDI 12d26eb6-113b-44e1-90e4-1e860873d42a 34 fields · synced Jun 8, 2026