Identity
- Trade Name
- MANZA HA NON-CEMENTED CUP FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- MANZA HA NON-CEMENTED CUP MULTI HOLE, 64MM FDA UDI
- Model / Reference
- 101-20-064 FDA UDI
- Description
- MANZA HA NON-CEMENTED CUP MULTI HOLE, 64MM FDA UDI
Identifiers
- Catalog Number
- 101-20-064 FDA UDI
- Primary DI / UDI-DI
- 00841176102354 FDA UDI
- 510(k) Number
- K153131 FDA UDI
- FDA Product Code
- LPH FDA UDIMEH FDA UDIKWZ FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3358 FDA UDI888.3353 FDA UDI888.3310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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: Acetabular shell
Manza Ha Non-Cemented Cup by Stinson Orthopedics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Logical 20° Hooded Liner — SIGNATURE ORTHOPAEDICS PTY LTD
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
- Stinson Orthopedics Inc.
Sources (1)
- FDA UDI 03dfb914-a30c-4d82-a2a7-6b75e4ca3b6e 35 fields · synced May 30, 2026