FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 10705034706962
·
Model: SD388.474
·
Synthes GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10705034706962
- Version / Model
- SD388.474
- Catalog Number
- SD388474
- Company Name
- Synthes GmbH
- Labeler DUNS
- 486711679
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-31
- Public Version
- 3
- Public Version Date
- 2022-04-26
- Public Version Status
- Update
- Public Device Record Key
- 0eb84ef5-61cb-4345-a341-21bbc7f0d6d1
Device Description
LOCK CRIMPER 45 DEG
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 |
|---|---|---|---|---|
| HXQ | CRIMPER, PIN | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32879 | Orthopaedic wire crimper | A hand-held manual surgical instrument designed like wire-closing forceps and used to bend wire or cerclage. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Secondary | H981SD3884740 | HIBCC | ||||
| Primary | 10705034706962 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]