FDA UDI
Not in Commercial Distribution
🇺🇸 United States
VERASENSE for Zimmer Biomet Persona
DI: 00816818021485
·
Model: VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right
·
ORTHOSENSOR INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VERASENSE for Zimmer Biomet Persona
- Primary DI
- 00816818021485
- Version / Model
- VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right
- Catalog Number
- ZBH-PSNCRCD39-R
- Company Name
- ORTHOSENSOR INC
- Labeler DUNS
- 005788130
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-18
- Public Version
- 3
- Public Version Date
- 2023-07-31
- Public Version Status
- Update
- Public Device Record Key
- 7a129cfe-b620-452d-b20a-3d4b1fc55e1a
- Distribution End Date
- 2023-06-30
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| ONN | Intraoperative Orthopedic Joint Assessment Aid | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58988 | Arthroplasty force sensor | An electronic device designed for use during arthroplasty to facilitate assessment of joint function during implantation of prosthesis components, typically to evaluate bone resection lines, prosthesis size and positioning, and/or soft tissue tension. It is dedicated to a specific joint or type of prosthesis (e.g., total knee, reverse shoulder) and consists of a transducer pad for insertion between opposing joint surfaces. It may have an integrated digital display or communicate with an external display unit; some types include a noninvasive analogue-to-digital converter and image display controller. It is typically available as a left or right version. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816818021485 | GS1 |