Primary Device ID | B691SPCL021 |
NIH Device Record Key | 5d16f8ca-4ae1-4a25-839e-fe14e6191153 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Rapid Reboot Recovery Products |
Version Model Number | SP-CL02-1 |
Company DUNS | 080628101 |
Company Name | RAPID REBOOT RECOVERY PRODUCTS LLC |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
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 | true |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B691SPCL021 [Primary] |
IRP | Massager, Powered Inflatable Tube |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-07-20 |
Device Publish Date | 2021-07-12 |
B691SPREN1 | REGEN Control Unit |
B691SPREN031 | RR REGEN Control Unit + Three Attachments |
B691SPREN021 | RR REGEN Control Unit + Two Attachments |
B691SPREN011 | RR REGEN Control Unit + Single Attachment |
B691SPGEN031 | RR GENESIS Control Unit + Three Attachments |
B691SPGEN021 | RR GENESIS Control Unit + Two Attachments |
B691SPGEN011 | RR GENESIS Control Unit + Single Attachment |
B691SPCL031 | RR CLASSIC Control Unit + Three Attachments |
B691SPCL021 | RR CLASSIC Control Unit + Two Attachments |
B691SPCL011 | RR CLASSIC Control Unit + Single Attachment |