IMAK RSI

GUDID 00082161600008

WRISTIMER®

BROWNMED, INC.

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• Primary Device ID: 00082161600008
• NIH Device Record Key: 81abd707-9fb7-4448-bb37-2108c8e68dfa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMAK RSI
• Version Model Number: 60000
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00082161600008 [Primary]

FDA Product Code

• IRA: Hand, External Limb Component, Mechanical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-03
• Device Publish Date: 2020-08-26

On-Brand Devices [IMAK RSI]

• 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