Identity
- Trade Name
- Arthroscopic Positioners FDA UDI
- Generic Name
- Freestanding patient positioner, single-use FDA UDI
- Device Name
- Well Leg Holder 32" X 10" X 5"- 30-115-00 - 10810044960201 Knee Holder 11.5" x 10.5" x 3" - 30-116-00 - 00810044961256 FDA UDI
- Model / Reference
- 30-800-00 (30-115-00 & 30-116-00) FDA UDI
- Description
- Well Leg Holder 32" X 10" X 5"- 30-115-00 - 10810044960201 Knee Holder 11.5" x 10.5" x 3" - 30-116-00 - 00810044961256 FDA UDI
Identifiers
- Catalog Number
- 30-800-00 (30-115-00 & 30-116-00) FDA UDI
- Primary DI / UDI-DI
- 00810044961263 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Freestanding patient positioner, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 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
Yes
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Freestanding patient positioner, single-use
Arthroscopic Positioners by Geneva Healthcare, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Geneva Healthcare, Llc
Sources (1)
- FDA UDI fc407ce4-b2a1-4593-a600-631ca1958b4a 35 fields · synced Jun 1, 2026