FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10886982240262
·
Model: 530.791
·
Synthes GmbH
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10886982240262
- Version / Model
- 530.791
- Catalog Number
- 530791
- Company Name
- Synthes GmbH
- Labeler DUNS
- 486711679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-22
- Public Version
- 4
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 76904e68-0c8e-441f-8873-db014ba59f6c
Device Description
QUICK COUPLING FOR K-WIRES AND PINS Ø1.5 - 4.0MM
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
- No
- 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 |
|---|---|---|---|---|
| GEY | MOTOR, SURGICAL INSTRUMENT, AC-POWERED | General, Plastic Surgery | 878.4820 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43660 | Pin-driving power tool attachment | A device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a wire driving/insertion function when an appropriate orthopaedic pin is inserted (e.g., K-Wire). It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. The device may be of the micro or macro design. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07611819491861 | GS1 | ||||
| Secondary | H6795307910 | HIBCC | ||||
| Primary | 10886982240262 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]