FDA UDI
In Commercial Distribution
🇺🇸 United States
Mobi-C® Plug & Fit US
DI: 03662663000178
·
Model: MB3577
·
LDR Spine Usa, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mobi-C® Plug & Fit US
- Primary DI
- 03662663000178
- Version / Model
- MB3577
- Company Name
- LDR Spine Usa, Inc.
- Labeler DUNS
- 615789729
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 6
- Public Version Date
- 2022-03-10
- Public Version Status
- Update
- Public Device Record Key
- b45fcb64-fde3-45c5-ad44-06fe206ec85a
Device Description
Total Cervical Disc Replacement System: Mobi-C Cervical Disc Prosthesis
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 Conditional
- 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 |
|---|---|---|---|---|
| MJO | Prosthesis, Intervertebral Disc | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48164 | Cervical total intervertebral disc prosthesis, modular | An implantable three-component assembly of devices intended to replace a dysfunctional intervertebral disc in the cervical spine that is comprised of an upper and lower endplate for attachment to adjacent vertebrae, and a space-occupying core between the plates to allow small movements of the adjacent vertebrae. The endplates are typically made of metal, and the core ceramic or synthetic polymer materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03662663000178 | GS1 |
Customer Contacts
- Phone
- 512-344-3333
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Height | 7 | Millimeter | |
| Width | 17 | Millimeter | |
| Depth | 15 | Millimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry, protect from sunlight