Identity
- Trade Name
- Axis FDA UDI
- Generic Name
- Passive shoulder prosthesis FDA UDI
- Device Name
- Nudge Kit, Black FDA UDI
- Model / Reference
- SJ45 FDA UDI
- Description
- Nudge Kit, Black FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841747175565 FDA UDI
- FDA Product Code
- IQQ FDA UDI
- GMDN Term
- Passive shoulder prosthesis FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3420 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Passive shoulder prosthesis
Axis by College Park Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Passive shoulder prosthesis.
- Axis — COLLEGE PARK INDUSTRIES, INC. · Class I
- Axis — COLLEGE PARK INDUSTRIES, INC. · Class I
- Axis — COLLEGE PARK INDUSTRIES, INC. · Class I
- Axis — COLLEGE PARK INDUSTRIES, INC. · Class I
- Axis — COLLEGE PARK INDUSTRIES, INC. · Class I
- Axis — COLLEGE PARK INDUSTRIES, INC. · Class I
- Axis — COLLEGE PARK INDUSTRIES, INC. · Class I
- Axis — COLLEGE PARK INDUSTRIES, INC. · Class I
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
- College Park Industries, Inc.
Sources (1)
- FDA UDI 948f5ddc-0d57-4bd7-b1cf-2a1f3a470610 34 fields · synced May 31, 2026