TenoMend

GUDID 00813954020709

Collagen Tendon Wrap

COLLAGEN MATRIX, INC.

Multi-purpose surgical mesh, collagen, bioabsorbable

• Primary Device ID: 00813954020709
• NIH Device Record Key: 68bc60e7-e640-4267-9446-5aba434e405f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TenoMend
• Version Model Number: CTW12025
• Company DUNS: 176262442
• Company Name: COLLAGEN MATRIX, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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	00813954020709 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080452

FDA Product Code

• FTM: Mesh, Surgical

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: 2018-07-06
• Device Publish Date: 2015-10-23

On-Brand Devices [TenoMend]

• 00813954020730: Collagen Tendon Wrap
• 00813954020723: Collagen Tendon Wrap
• 00813954020716: Collagen Tendon Wrap
• 00813954020709: Collagen Tendon Wrap
• 00813954020693: Collagen Tendon Wrap
• 00813954020686: Collagen Tendon Wrap