TAPESTRY Biointegrative Implant with Introducer TR-4030-21

GUDID 00810063820114

TAPESTRY Biointegrative Implant with Introducer, Anterior, 40mm x 30mm

Embody, Inc.

Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite

• Primary Device ID: 00810063820114
• NIH Device Record Key: 4a630e76-4dfe-41d2-9804-8160926ffbb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TAPESTRY Biointegrative Implant with Introducer
• Version Model Number: TR-4030-21
• Catalog Number: TR-4030-21
• 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	00810063820114 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220867

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: 2022-06-09
• Device Publish Date: 2022-06-01

On-Brand Devices [TAPESTRY Biointegrative Implant with Introducer]

• 00810063820145: TAPESTRY Biointegrative Implant with Introducer, Lateral, 40mm x 30mm
• 00810063820138: TAPESTRY Biointegrative Implant with Introducer, Lateral, 30mm x 30mm
• 00810063820121: TAPESTRY Biointegrative Implant with Introducer, Lateral, 20mm x 30mm
• 00810063820114: TAPESTRY Biointegrative Implant with Introducer, Anterior, 40mm x 30mm
• 00810063820107: TAPESTRY Biointegrative Implant with Introducer, Anterior, 30mm x 30mm
• 00810063820091: TAPESTRY Biointegrative Implant with Introducer, Anterior, 20mm x 30mm
• 00810063820466: TAPESTRY Biointegrative Implant with Introducer, Lateral, 26mm x 26mm
• 00810063820459: TAPESTRY Biointegrative Implant with Introducer, Anterior, 26mm x 26mm