FDA UDI
In Commercial Distribution
🇺🇸 United States
Offset Cup Impactor 7/16-20 UNF Long = 3mm
DI: 07640187917161
·
Model: T18303
·
MPS Micro Precision Systems AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Offset Cup Impactor 7/16-20 UNF Long = 3mm
- Primary DI
- 07640187917161
- Version / Model
- T18303
- Catalog Number
- T18303
- Company Name
- MPS Micro Precision Systems AG
- Labeler DUNS
- 482204059
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-26
- Public Version
- 4
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- a5b782d8-9baf-409b-82e5-7a2286d1c24a
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HWA | Impactor | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32856 | Orthopaedic implant impactor, reusable | A non-powered, hand-held, surgical instrument designed to transmit impact forces, typically from a hammer/mallet to an orthopaedic implant (e.g., intramedullary nail or stem), to position/drive the implant into the body during impact-based implantation. It commonly includes an impact-absorbing handle with a distal end shaped to conform to the implant (i.e., flat or anatomically curved). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640187917161 | GS1 |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]