LipAlign

GUDID 00860010953945

Cleft Lip Approximation Tape Size Medium

Cleftalign Inc.

Skin-closure adhesive strip

• Primary Device ID: 00860010953945
• NIH Device Record Key: 2afe7542-a8a2-4adb-9d73-b66b4e0a753a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LipAlign
• Version Model Number: LAT-M
• 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	00860010953945 [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: 2024-08-28
• Device Publish Date: 2024-08-20

On-Brand Devices [LipAlign]

• 00860010953952: Cleft Lip Approximation Tape Size Small
• 00860010953945: Cleft Lip Approximation Tape Size Medium
• 00860010953938: Cleft Lip Approximation Tape Size Large