FDA UDI
In Commercial Distribution
🇺🇸 United States
Lumbar Interbody Fusion System (OLLIF)
DI: 00850014575649
·
Model: 01-14-4
·
ADVANCED RESEARCH MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Lumbar Interbody Fusion System (OLLIF)
- Primary DI
- 00850014575649
- Version / Model
- 01-14-4
- Catalog Number
- 01-14-4
- Company Name
- ADVANCED RESEARCH MEDICAL LLC
- Labeler DUNS
- 117201206
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-08-16
- Public Version
- 1
- Public Version Date
- 2021-08-24
- Public Version Status
- New
- Public Device Record Key
- 877cb02e-1dfc-462e-ba17-43af19735b25
Device Description
Lumbar Interbody Fusion System (OLLIF) Handheld Microscope - Light Guide
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
- 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 |
|---|---|---|---|---|
| 37089 | Light source adaptor | A small connecting device designed to permit the connection of the devices that together deliver light to a work field from a light source. This device is used to connect together products of dissimilar manufacture and dimensions, e.g., a fibreoptic light cable of one manufacture to the light source of another. It may also be used at the instrument end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850014575649 | GS1 |
Customer Contacts
- Phone
- 6124401865
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173947 | 000 |