FDA UDI
In Commercial Distribution
🇺🇸 United States
ReActiv8 IPG
DI: 05391527770015
·
Model: 7M5100-002
·
MAINSTAY MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ReActiv8 IPG
- Primary DI
- 05391527770015
- Version / Model
- 7M5100-002
- Catalog Number
- 5100
- Company Name
- MAINSTAY MEDICAL LIMITED
- Labeler DUNS
- 985519015
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-01-25
- Public Version
- 1
- Public Version Date
- 2021-02-02
- Public Version Status
- New
- Public Device Record Key
- e318cb7d-6145-4530-a634-987d8381d0ef
Device Description
ReActiv8 Implantable Pulse Generator
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 Unsafe
- 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 |
|---|---|---|---|---|
| QLK | Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62422 | Implantable lumbar neuromuscular electrical stimulation system pulse generator | A sterile, implantable, electronic component of an implantable lumbar neuromuscular electrical stimulation system intended to deliver episodic electrical stimulation to nerves that innervate lumbar muscles to elicit contraction for the treatment of chronic low back pain (CLBP). It is a battery-powered electrical pulse generator, typically implanted in a subcutaneous pocket in the low back region, which has connections for electrical leads (not included). The device is programmed, controlled and charged telemetrically by external devices. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391527770015 | GS1 |
Customer Contacts
- Phone
- 877-702-8488
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P190021 | 000 |