mBrace Wrist Support 140-0200-00

GUDID 10815614020125

The mBrace Model 4200 is a wrist support device that extends the patient's wrist at a consistent 40° angle.

SEMLER TECHNOLOGIES, INC.

Wrist immobilizer, single-use

• Primary Device ID: 10815614020125
• NIH Device Record Key: 919edef6-0cc3-491b-9324-a3fd4c9bc5c1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mBrace Wrist Support
• Version Model Number: 4200
• Catalog Number: 140-0200-00
• Company DUNS: 042075700
• Company Name: SEMLER TECHNOLOGIES, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10815614020125 [Primary]
GS1	20815614020122 [Package]; Package: Case [30 Units]; In Commercial Distribution

FDA Product Code

• FMQ: Restraint, Protective

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: 2022-11-23
• Device Publish Date: 2022-11-15

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