NoseAlign

GUDID 00860010953914

Cleft Nose Approximation Device Size # 2

Cleftalign Inc.

Skin-closure adhesive strip

• Primary Device ID: 00860010953914
• NIH Device Record Key: c1c006c8-a83a-4cb1-89e6-cf21f7310063
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NoseAlign
• Version Model Number: NAS 02
• Company DUNS: 118148461
• Company Name: Cleftalign 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010953914 [Primary]

FDA Product Code

• MZR: Topical Approximation System

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: 2023-12-04
• Device Publish Date: 2023-11-24

On-Brand Devices [NoseAlign]

• 00860010953921: Cleft Nose Approximation Device Size # 3
• 00860010953914: Cleft Nose Approximation Device Size # 2
• 00860010953907: Cleft Nose Approximation Device Size # 1