Primary Device ID | 00810020080759 |
NIH Device Record Key | 8719cadf-fa67-47d9-a008-85fe6167be3c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MedLED Spectra |
Version Model Number | MG6-SK |
Company DUNS | 964053560 |
Company Name | RIVERPOINT MEDICAL, LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | true |
Manufacturing Date | true |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00810020080759 [Primary] |
HPP | Headlamp, Operating, Battery-Operated |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-10 |
Device Publish Date | 2023-10-02 |
00810020080759 | Standard Kit |
00810020080704 | Standard Kit |
00810020080698 | Hospital Kit |
00810020080384 | Headlamp |
00810020080377 | Headlamp |
10840277402704 | Rechargeable Battery Set |
00840277404008 | MedLED Spectra® Headband Assembly |
00840277403445 | Carrying Bag Rugged |
00840277403216 | Charger 16-Bay Set |
00840277403209 | Charger 16-Bay Console |
00840277402752 | Headstrap Top Kit |
00840277402738 | Charger 4-Bay Console |
00840277402714 | Charger Wall Console |
00810020086683 | MG8 Bezel System Assembly |
00810020085815 | Rechargeable Battery Set (1 pc.) |
00810020086621 | MG8 Standard Kit Incl Headlamp Assembly, Carry Case |
00810020086614 | MG8 Hospital Kit Incl Headlamp Assembly, Carry Case |
00810020086607 | MG3/6/8 Standard Kit |
00810020086591 | MG3/6/8 Includes 3 Bezels Headlamp Assembly, Carrying Case |
00810020086584 | DEMO - MG3/6/8 Headstrap, Bezels, Batteries, & Plugs |
00810020080742 | MG6 Hospital Kit Incl Headlamp Assembly, Carry Case |
00840277404176 | Charger USB Cable |
00840277404169 | Charger USB Cable |
00840277403193 | Charger 4-Bay Set (US) |
00840277402721 | Charger Wall Set (INT'L) |