Primary Device ID | 00082161605003 |
NIH Device Record Key | 17c387ad-4a7f-4de0-97af-b9a6cd27e5bb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IMAK RSI |
Version Model Number | 60500 |
Company DUNS | 091999771 |
Company Name | BROWNMED, INC. |
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 | 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 | true |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00082161605003 [Primary] |
IRA | Hand, External Limb Component, Mechanical |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-09-03 |
Device Publish Date | 2020-08-26 |
00649833201651 | Smart Glove w/Thumb |
00649833201637 | Smart Glove w/Thumb |
00649833201620 | Smart Glove w/Thumb |
00649833201613 | Smart Glove w/Thumb |
00649833201286 | Computer Glove |
00649833201279 | Smart Glove |
00649833201262 | Smart Glove |
00649833201255 | Smart Glove |
00649833201118 | Smart Glove |
00649833101111 | Smart Glove PM |
00649833103122 | Pil-O-Splint |
00649833103016 | Elbow Band |
00649833101722 | Elbow Support PM |
00649833101135 | Elbow Support |
00649833101128 | Pil-O-Splint |
00082161605003 | WRISTIMER PM® |
00082161600206 | WRISTIMER® |
00082161600107 | WRISTIMER® |
00082161600008 | WRISTIMER® |
00649833301412 | Arm Sling with Immobilizer |
00649833301405 | Arm Sling |
00649833301375 | Knee Strap |