AVD Transradial Access Drape 170-0100-01

GUDID 10815614020446

Model 7100, Radial Drape, Single Hole

SEMLER TECHNOLOGIES, INC.

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• Primary Device ID: 10815614020446
• NIH Device Record Key: 25c31c0b-034f-4cd8-9118-d9439c600ce8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVD Transradial Access Drape
• Version Model Number: 7100
• Catalog Number: 170-0100-01
• 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: false
• Expiration Date: true
• 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	10815614020446 [Primary]
GS1	20815614020443 [Package]; Package: Case [25 Units]; In Commercial Distribution

FDA Product Code

• PUI: Drape, Surgical, Exempt

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-06-14
• Device Publish Date: 2016-09-24

On-Brand Devices [AVD Transradial Access Drape]

• 10815614020712: Model 4501 Special Procedures Drape, Single hole.
• 20815614020450: Model 7200, Radial/Brachial Drape, Two hole
• 10815614020446: Model 7100, Radial Drape, Single Hole
• 20815614020436: Model 4500 Special Procedures Drape, Single hole.