FDA UDI
In Commercial Distribution
🇺🇸 United States
Rampart O
DI: M7402800034
·
Model: 83-04-07-40
·
SPINEOLOGY INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Rampart O
- Primary DI
- M7402800034
- Version / Model
- 83-04-07-40
- Catalog Number
- 280-0034
- Company Name
- SPINEOLOGY INC.
- Labeler DUNS
- 033014361
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-28
- Public Version
- 1
- Public Version Date
- 2018-09-28
- Public Version Status
- New
- Public Device Record Key
- 88fc7dfa-7937-4d40-a145-8c7fd2bd4c02
Device Description
10x40mm Trial
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 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 | M7402800034 | HIBCC |
Customer Contacts
- Phone
- +1(651)256-8500 ext. 513
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160906 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 10 | Millimeter | |
| Device Size Text, specify | 10x40mm Trial |