Dual Anchor Inserter with Bioabsorbable Anchors TR-0001-21

GUDID 00810063820152

The Bioabsorbable Anchor is an absorbable implant device that is intended to provide fixation of a prosthetic material to soft tissue and/or bone. The Bioabsorbable Anchor is composed of polydioxanone dyed with D&C Violet No. 2. Two each of the Bioabsorbable Anchors are provided sterile for single-use only and are packaged preloaded in a single anchor inserter instrument, the Dual Anchor Inserter, in a dual sterile pouch configuration.

Embody, Inc.

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• Primary Device ID: 00810063820152
• NIH Device Record Key: 606645d0-77d2-4af0-a133-91771865902b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Anchor Inserter with Bioabsorbable Anchors
• Version Model Number: TR-0001-21
• Catalog Number: TR-0001-21
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810063820152 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213958

FDA Product Code

• MAI: Fastener, Fixation, Biodegradable, Soft Tissue

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: 2022-05-17
• Device Publish Date: 2022-05-09

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