Identity
- Trade Name
- Offset Cup Impactor 7/16-20 UNF Long = 3mm FDA UDI
- Generic Name
- Orthopaedic implant impactor, reusable FDA UDI
- Device Name
- Offset cup impactors are to be used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. The cup impactor is equipped with a suitable connection system to the acetabular cup (e.g. a thread). A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument. This is an reusable device. FDA UDI
- Model / Reference
- T18303 FDA UDI
- Description
- Offset cup impactors are to be used to position and seat acetabular cups into the reamed acetabulum during hip joint replacement surgery. The cup impactor is equipped with a suitable connection system to the acetabular cup (e.g. a thread). A hammer is used to deliver the necessary impact to an anvil (or impactor disc) at the rear end of the instrument. This is an reusable device. FDA UDI
Identifiers
- Catalog Number
- T18303 FDA UDI
- Primary DI / UDI-DI
- 07640187917161 FDA UDI
- FDA Product Code
- HWA FDA UDI
- GMDN Term
- Orthopaedic implant impactor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic implant impactor, reusable
Offset Cup Impactor 7/16-20 UNF Long = 3mm by MPS Micro Precision Systems AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Orthopaedic implant impactor, reusable.
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- R3 — Smith & Nephew, 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
- MPS Micro Precision Systems AG
Sources (1)
- FDA UDI a5b782d8-9baf-409b-82e5-7a2286d1c24a 35 fields · synced May 29, 2026