Primary Device ID | 05391527772071 |
NIH Device Record Key | c6422739-1518-4ff5-a246-9f92dd0dbbf8 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ReActiv8 Stimulation Lead |
Version Model Number | 7M8145-006 |
Catalog Number | 8145 |
Company DUNS | 985519015 |
Company Name | MAINSTAY MEDICAL LIMITED |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Unsafe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 05391527772071 [Primary] |
QLK | Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-02-02 |
Device Publish Date | 2021-01-25 |
05391527772279 | Stimulation Lead, 65 cm length, Assembled, tray packed, and sterilized at Oscor Caribe, then fin |
05391527772262 | Stimulation Lead, 65 cm length, Assembled and tray packed at OC, then sterilized and final packa |
05391527772071 | Assembled, tray packed, and sterilized at Oscor Caribe, then final packaged at Oscor, Inc. |
05391527772064 | Stimulation Lead, 45 cm length, Assembled and tray packed at Oscor Caribe, then sterilized and f |