FDA UDI
In Commercial Distribution
🇺🇸 United States
ShurFit Lumbar Interbody
DI: 00840019952255
·
Model: 72-OPC-3616
·
PRECISION SPINE, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ShurFit Lumbar Interbody
- Primary DI
- 00840019952255
- Version / Model
- 72-OPC-3616
- Catalog Number
- 72-OPC-3616
- Company Name
- PRECISION SPINE, INC.
- Labeler DUNS
- 079398589
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-16
- Public Version
- 1
- Public Version Date
- 2023-03-24
- Public Version Status
- New
- Public Device Record Key
- 8e262024-1d59-4789-890c-1fbdb33c722b
Device Description
36 x 16mm 12° Oblique PEEK Interbody
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60706 | Extra-gynaecological surgical mesh, silk, non-bioabsorbable | A non-bioabsorbable, implantable material (e.g., flat sheet) made from silk (derived from domesticated silkworms) intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840019952255 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K212075 | 000 |