mBrace 4285 Wrist Support with Hook 140-0285-00

GUDID 10815614021092

The mBrace Model 4285 is a wrist support device that extends the patient's wrist at a consistent 30°angle with a syringe clip to attach a syringe and with a hook to integrate with an ArmBoard. The mBrace Model 4285 has a valley in the area below the wrist to allow a hemostasis device strap to be easily applied.

Semler Technologies, Inc.

Wrist immobilizer, single-use

• Primary Device ID: 10815614021092
• NIH Device Record Key: b07e11db-5f6c-4e80-b24f-3aa11cc18a4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mBrace 4285 Wrist Support with Hook
• Version Model Number: 4285
• Catalog Number: 140-0285-00
• 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	10815614021092 [Primary]
GS1	20815614021099 [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: 2025-03-07
• Device Publish Date: 2025-02-27

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