IMAK RSI

GUDID 00649833103016

Elbow Band

BROWNMED, INC.

Elbow joint orthosis component
Primary Device ID00649833103016
NIH Device Record Key24b2994c-32f9-4881-81db-4c9da916b864
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMAK RSI
Version Model NumberA10301
Company DUNS091999771
Company NameBROWNMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100649833103016 [Primary]

FDA Product Code

IOYSupport, Arm

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-03
Device Publish Date2020-08-26

On-Brand Devices [IMAK RSI]

00649833201651Smart Glove w/Thumb
00649833201637Smart Glove w/Thumb
00649833201620Smart Glove w/Thumb
00649833201613Smart Glove w/Thumb
00649833201286Computer Glove
00649833201279Smart Glove
00649833201262Smart Glove
00649833201255Smart Glove
00649833201118Smart Glove
00649833101111Smart Glove PM
00649833103122Pil-O-Splint
00649833103016Elbow Band
00649833101722Elbow Support PM
00649833101135Elbow Support
00649833101128Pil-O-Splint
00082161605003WRISTIMER PM®
00082161600206WRISTIMER®
00082161600107WRISTIMER®
00082161600008WRISTIMER®
00649833301412Arm Sling with Immobilizer
00649833301405Arm Sling
00649833301375Knee Strap

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