FDA UDI
In Commercial Distribution
🇺🇸 United States
JAZZ System
DI: 03607503501576
·
Model: JAZZ Passer Band
·
IMPLANET
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- JAZZ System
- Primary DI
- 03607503501576
- Version / Model
- JAZZ Passer Band
- Catalog Number
- 350157
- Company Name
- IMPLANET
- Labeler DUNS
- 291993439
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-03-21
- Public Version
- 2
- Public Version Date
- 2019-09-26
- Public Version Status
- Update
- Public Device Record Key
- f95174db-ec54-44db-ae8a-51677e88fc81
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OWI | Bone Fixation Cerclage, Sublaminar | Orthopedic | 888.3010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37272 | Trans-facet-screw internal spinal fixation system, sterile | A sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03607503501576 | GS1 |