FDA UDI
In Commercial Distribution
🇺🇸 United States
ReActiv8 Stimulation Lead
DI: 05391527772279
·
Model: 7M8165-006
·
MAINSTAY MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ReActiv8 Stimulation Lead
- Primary DI
- 05391527772279
- Version / Model
- 7M8165-006
- Catalog Number
- 8165
- 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
- 3
- Public Version Date
- 2021-06-08
- Public Version Status
- Update
- Public Device Record Key
- 19b21841-c4c3-43ff-b018-6418b4ab70a5
Device Description
Stimulation Lead, 65 cm length, Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc.
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 |
|---|---|---|---|---|
| 62423 | Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection | An electrically-insulated wire with a distal electrode intended to be implanted into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for wired transmission of electrical impulses from a co-implanted pulse generator (not included), to the target nerves, for the relief/treatment of acute and/or chronic intractable pain. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05391527772279 | GS1 |
Customer Contacts
- Phone
- 877-702-8488
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P190021 | 000 |