FDA UDI
In Commercial Distribution
🇺🇸 United States
VV-PLUG
DI: 00802526497544
·
Model: 667145-301
·
Oscor Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VV-PLUG
- Primary DI
- 00802526497544
- Version / Model
- 667145-301
- Catalog Number
- VV-PLUG
- Company Name
- Oscor Inc.
- Labeler DUNS
- 101835833
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-07
- Public Version
- 5
- Public Version Date
- 2021-03-19
- Public Version Status
- Update
- Public Device Record Key
- b43451de-218f-4c30-8ef5-7fca7d27b725
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | Cardiovascular | 870.3680 | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44900 | Implantable pulse generator port plug | A non-active implantable device designed for insertion into the vacant/unused connector port of an implantable pulse generator (e.g., cardiac pacemaker/defibrillator, neurostimulator) to seal and electrically isolate the port, and to protect the parent device. It is typically made of metal and/or polymer materials. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00802526497544 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K031164 | 000 |