FDA UDI
In Commercial Distribution
🇺🇸 United States
Omnia
DI: 00813426020565
·
Model: CHGR2500
·
NEVRO CORP.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Omnia
- Primary DI
- 00813426020565
- Version / Model
- CHGR2500
- Catalog Number
- CHGR2500
- Company Name
- NEVRO CORP.
- Labeler DUNS
- 926599155
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-11
- Public Version
- 4
- Public Version Date
- 2021-01-25
- Public Version Status
- Update
- Public Device Record Key
- 14f9b418-f727-458d-acb0-4b15e85a7ef8
Device Description
Charger 2500 Kit
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LGW | Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33658 | Implant battery charger | An electronic device intended to be used to wirelessly recharge the batteries of an active implantable device in situ. It is not intended to program or extract data from (read) the implanted device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813426020565 | GS1 |
Customer Contacts
- Phone
- 6502510005
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P130022 | 000 |