FDA UDI
In Commercial Distribution
🇺🇸 United States
IsoTis® Facet Fusion Instruments
DI: 10889981321826
·
Model: 02-9100-001
·
Seaspine Orthopedics Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- IsoTis® Facet Fusion Instruments
- Primary DI
- 10889981321826
- Version / Model
- 02-9100-001
- Catalog Number
- 02-9100-001
- Company Name
- Seaspine Orthopedics Corporation
- Labeler DUNS
- 079840876
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-04
- Public Version
- 2
- Public Version Date
- 2025-10-24
- Public Version Status
- Update
- Public Device Record Key
- 50799dc2-f133-40f1-b5d6-d543a50f480a
Device Description
IsoTis® Facet Fusion Instruments
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
- Yes
- 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 |
|---|---|---|---|---|
| OLO | Orthopedic stereotaxic instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44052 | Orthopaedic surgical procedure kit, non-medicated, single-use | A collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10889981321826 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243659 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius