Tapestry Biointegrative Implant

GUDID 00810063820077

provided with insertion sleeve

Embody, Inc.

Extra-gynaecological surgical mesh, biologic-polymer composite

• Primary Device ID: 00810063820077
• NIH Device Record Key: 48b6b8da-66b7-4881-8ff5-f100ea064d89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tapestry Biointegrative Implant
• Version Model Number: TS-4030-02
• Company DUNS: 079544913
• Company Name: Embody, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	00810063820077 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201572

FDA Product Code

• OWY: Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-19
• Device Publish Date: 2023-05-11

On-Brand Devices [Tapestry Biointegrative Implant]

• 00810063820053: TP-4030-01
• 00810063820046: TP-3030-01
• 00810063820022: TP-2550-01
• 00810063820015: TP-7025-02
• 00810063820060: Provided with Insertion Sleeve.
• 00810063820084: Tapestry Biointegrative Implant Insertion Sleeve
• 00810063820077: provided with insertion sleeve
• 00810063820039: TP-2030-01