FDA UDI
In Commercial Distribution
🇺🇸 United States
Gimmi
DI: 04049047705536
·
Model: KC.1678.20
·
Gimmi GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Gimmi
- Primary DI
- 04049047705536
- Version / Model
- KC.1678.20
- Catalog Number
- KC.1678.20
- Company Name
- Gimmi GmbH
- Labeler DUNS
- 316152610
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-14
- Public Version
- 1
- Public Version Date
- 2025-05-22
- Public Version Status
- New
- Public Device Record Key
- be3470bb-d944-48d3-a114-cbe8d83edca8
Device Description
TENDON SEIZING INSTRUMENT LENGTH 205 MM
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 |
|---|---|---|---|---|
| 17674 | Tendon approximator | One of a pair or set of surgical instruments used to grasp the torn or resected portions of a tendon to hold the portions in apposition for the purpose of reattaching one portion to the other in order to repair the structure. Also, an instrument used to grasp a tendon, or separated parts of a tendon, to position it in a surgical opening. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049047705536 | GS1 |
Customer Contacts
- Phone
- +497461965900
- [email protected]