FDA UDI
In Commercial Distribution
🇺🇸 United States
Mobi-C Plug & Fit US
DI: 03662663059084
·
Model: MB3574
·
ZIMMER BIOMET INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Mobi-C Plug & Fit US
- Primary DI
- 03662663059084
- Version / Model
- MB3574
- Company Name
- ZIMMER BIOMET INC
- Labeler DUNS
- 045576443
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-05
- Public Version
- 3
- Public Version Date
- 2025-01-03
- Public Version Status
- Update
- Public Device Record Key
- 2834428a-b4b6-4fa6-b5d9-d33fdb724328
Device Description
US MOBI-C M"STANDARD" IMPLANT 15x17 H4.5
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 | 03662663059084 | GS1 |
Customer Contacts
- Phone
- 1(800)447-3625
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 15 | Millimeter | |
| Width | 17 | Millimeter |