FDA UDI
Not in Commercial Distribution
🇺🇸 United States
SynFix-LR
DI: 10705034722276
·
Model: 03.802.042
·
SYNTHES (U.S.A.) LP
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- SynFix-LR
- Primary DI
- 10705034722276
- Version / Model
- 03.802.042
- Catalog Number
- 03802042
- Company Name
- SYNTHES (U.S.A.) LP
- Labeler DUNS
- 832637081
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-31
- Public Version
- 4
- Public Version Date
- 2020-09-17
- Public Version Status
- Update
- Public Device Record Key
- a2bc6aa4-9ed1-4f64-b5b4-a8bd85ee0a80
- Distribution End Date
- 2020-09-17
Device Description
PACKING BLOCK FOR 30MM DEPTH/ 38MM WIDTH SYNFIX(TM)-LR
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 |
|---|---|---|---|---|
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47743 | Bone graft packing block | A device designed to tightly compact (pack) an implant with a bone graft material (e.g., autologous, allogeneic, xenogeneic, or of synthetic origin) prior to the implantation of the implant. It is typically a small, box-shaped device consisting of two parts, a frame to hold the implant to be filled and a fitted lid that stabilizes the implant while it is being filled. The packing of the implant is done manually, typically with an impactor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07611819297425 | GS1 | ||||
| Secondary | H981038020420 | HIBCC | ||||
| Primary | 10705034722276 | GS1 |
Customer Contacts
- Phone
- +1(800)255-2500
- [email protected]