FDA UDI
In Commercial Distribution
🇺🇸 United States
Hook
DI: 07640187910490
·
Model: T14587
·
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
- Hook
- Primary DI
- 07640187910490
- Version / Model
- T14587
- Catalog Number
- T14587
- 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
- 2020-08-20
- Public Version
- 3
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- f10b10e3-f527-4754-bf6a-008eb38a4711
Device Description
Hook, in combination with the slap hammer, is intended to help the surgeon to pull/liberate the components in area where the access, due to soft tissues, is limited. When the instrument is placed at the femoral distal trochlea groove, it is ideal for pulling off the femoral implant. 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 |
|---|---|---|---|---|
| 12696 | Orthopaedic inorganic implant inserter/extractor, reusable | A hand-held manual surgical instrument designed for the surgical insertion and/or extraction of a non-tissue based (inorganic) orthopaedic implant (e.g., a bone nail, spiral blade, or bone fixation plate). It is an instrument in a one-piece or modular configuration with a region that will attach/fit/lock to part of the implant, and typically features either a mechanism to apply a striking force (e.g., on a pad/flange) a mechanism for twisting (screwing) (e.g., T-handle), or a plunger mechanism to deploy a guide to drive the implant into place. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640187910490 | GS1 |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]