Identity
- Trade Name
- ESOP® FDA UDI
- Generic Name
- Acetabular shell FDA UDI
- Model / Reference
- 245094 - ACETABULAR LINER/PE, Ø32 / Ø68 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489450945 FDA UDI
- 510(k) Number
- K961388 FDA UDI
- FDA Product Code
- MEH 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
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
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
Esop® by Fournitures Hospitalieres Industrie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K961388 also covers:
- ACETABULAR REAMER D.48 — FOURNITURES HOSPITALIERES INDUSTRIE
- ACETABULAR REAMER D.50 — FOURNITURES HOSPITALIERES INDUSTRIE
- ACETABULAR REAMER D.52 — FOURNITURES HOSPITALIERES INDUSTRIE
- ACETABULAR REAMER D.54 — FOURNITURES HOSPITALIERES INDUSTRIE
- ACETABULAR REAMER D.60 — FOURNITURES HOSPITALIERES INDUSTRIE
- CONTAINER 550X265X175 — FOURNITURES HOSPITALIERES INDUSTRIE
- CONTAINER 60X30X20 — FOURNITURES HOSPITALIERES INDUSTRIE
- DRILL DIAMETER 4, 5 LG 36 — FOURNITURES HOSPITALIERES INDUSTRIE
- DRILL DIAMETER 4, 5 LG 70 — FOURNITURES HOSPITALIERES INDUSTRIE
- ESOP 12/25 ANTERIOR BROACH HANDLE — FOURNITURES HOSPITALIERES INDUSTRIE
- ESOP® — FOURNITURES HOSPITALIERES INDUSTRIE
- ESOP® — FOURNITURES HOSPITALIERES INDUSTRIE
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
- Fournitures Hospitalieres Industrie
Sources (1)
- FDA UDI 25e2c7d6-5f73-42d7-bfdd-3b440a908277 33 fields · synced May 30, 2026