FDA UDI
In Commercial Distribution
🇺🇸 United States
Puncher
DI: 07640187910506
·
Model: T14586
·
MPS Micro Precision Systems AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Puncher
- Primary DI
- 07640187910506
- Version / Model
- T14586
- Catalog Number
- T14586
- 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
- 3
- Public Version Date
- 2022-11-18
- Public Version Status
- Update
- Public Device Record Key
- 562b0167-650c-45bd-974e-fdc5da5714ee
Device Description
A hand-held instrument used to, as soon as the femoral implant has been loosed by the chisel blade, for punching out the femoral implant. The extremity is applied proximal onto onto the femoral anterior flange for a stable and safe extraction.This is a 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 |
|---|---|---|---|---|
| LXH | Orthopedic Manual Surgical Instrument | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35048 | Bone lever/elevator, reusable | A manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640187910506 | GS1 |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]