FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Rampart T Lumbar Interbody Fusion Device
DI: M7403663508
·
Model: 10-10-72-12
·
SPINEOLOGY INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rampart T Lumbar Interbody Fusion Device
- Primary DI
- M7403663508
- Version / Model
- 10-10-72-12
- Catalog Number
- 366-3508
- Company Name
- SPINEOLOGY INC.
- Labeler DUNS
- 033014361
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-28
- Public Version
- 4
- Public Version Date
- 2021-05-05
- Public Version Status
- Update
- Public Device Record Key
- 0537f183-b6b3-4548-8604-9a09d0485bb5
- Distribution End Date
- 2021-05-04
Device Description
Spinal Implant
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
- MR Unsafe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
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 |
|---|---|---|---|---|
| 61609 | Vertebral body bone graft pouch | A sterile, implantable, mesh bag designed to contain and maintain the position of bone graft materials that have been implanted into a vertebral body defect, following bone tissue removal, to treat defects typically caused by trauma, deformity, tumours, or degenerative diseases. It is made of woven/knitted non-bioabsorbable synthetic polymer(s) material. Dedicated disposable devices associated with implantation may be included. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M7403663508 | HIBCC |
Customer Contacts
- Phone
- +1(651)256-8500 ext. 534
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 8x35 | ||
| Length | 8 | Millimeter |