Identity
- Trade Name
- TREGOR® FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Device Name
- Cemented cup FDA UDI
- Model / Reference
- 35127 FDA UDI
- Description
- Cemented cup FDA UDI
Identifiers
- Catalog Number
- 12600840 FDA UDI
- Primary DI / UDI-DI
- 03663703000370 FDA UDI
- FDA Product Code
- LZO FDA UDI
- GMDN Term
- Acetabular shell FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3353 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
Tregor® by Aston Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Acetabular shell.
- DJO SURGICAL — ENCORE MEDICAL, L.P. · Class II
- Klassic HD Acetabular Cup with Ti-Coat — TOTAL JOINT ORTHOPEDICS, INC. · Class II
- POLARCUP — Smith & Nephew, Inc. · Class II
- ESOP® — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- ESOP® — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
- InSitu Hip System — Nextstep Arthropedix · Class II
- REFLECTION — Smith & Nephew, Inc. · Class II
- Regenerex® Ringloc®+ Hip System — Biomet Orthopedics, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aston Medical
Sources (1)
- FDA UDI ddca29ea-9c6e-49a8-b451-d06040475754 36 fields · synced May 30, 2026