Identity
- Trade Name
- Hand Controller Sheath FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, sterile FDA UDI
- Device Name
- Avanta Single Use Hand Controller Sheath (ANGIO-AVANTA,SHEATH,HAND CONTROLLER,MC) (60729466) FDA UDI
- Model / Reference
- AVA 500 HCS FDA UDI
- Description
- Avanta Single Use Hand Controller Sheath (ANGIO-AVANTA,SHEATH,HAND CONTROLLER,MC) (60729466) FDA UDI
Identifiers
- Catalog Number
- AVA 500 HCS FDA UDI
- Primary DI / UDI-DI
- 00616258005348 FDA UDI
- 510(k) Number
- K050456 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- Instrument/equipment drape, single-use, sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
Yes
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
Yes
FDA UDI
Category: Instrument/equipment drape, single-use, sterile
Hand Controller Sheath by Bayer Medical Care Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Instrument/equipment drape, single-use, sterile.
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Cleared under the same submission
K050456 also covers:
- Avanta Hand Controller Sheath — Bayer Medical Care Inc.
- Display Control Unit Sheath — Bayer Medical Care Inc.
- Display Control Unit Sheath — Bayer Medical Care Inc.
- Display Control Unit Sheath — Bayer Medical Care Inc.
- Display Control Unit Sheath — Bayer Medical Care Inc.
- Display Control Unit Sheath — Bayer Medical Care Inc.
- Hand Controller Sheath — Bayer Medical Care Inc.
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc.
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc.
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc.
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care Inc.
- MEDRAD® Avanta Fluid Management Injection System — Bayer Medical Care 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
- Bayer Medical Care Inc.
Sources (1)
- FDA UDI 7f9d971e-158f-402a-927f-2ac399bb349b 36 fields · synced Jun 9, 2026