Suture Wing

GUDID 08800071005131

Suture Wing All Suture Anchor '1.7' 2Line(Teleflex)(USP#2)(White)(White/Blue)

OSTEONIC CO.,Ltd.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 08800071005131
• NIH Device Record Key: 0fdbc5f2-63b3-4c34-b38a-06cc88536a8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Suture Wing
• Version Model Number: ASA-2025-2160
• Company DUNS: 688999370
• Company Name: OSTEONIC CO.,Ltd.
• 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: true
• Expiration Date: false
• 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	08800071005131 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202663

FDA Product Code

• MBI: Fastener, Fixation, Nondegradable, 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: 2021-07-12
• Device Publish Date: 2021-07-02

On-Brand Devices [Suture Wing]

• 08800071005179: Suture Wing All Suture Anchor '1.7' 2Line(Teleflex)(USP#2)(White/Black)(White/Blue)
• 08800071005162: Suture Wing All Suture Anchor '1.7' 2Line(Teleflex)(USP#2)(White/Blue)(Blue)
• 08800071005155: Suture Wing All Suture Anchor '1.7' 2Line(Teleflex)(USP#2)(White/Black)(Blue)
• 08800071005148: Suture Wing All Suture Anchor '1.7' 2Line(Teleflex)(USP#2)(White)(Blue)
• 08800071005131: Suture Wing All Suture Anchor '1.7' 2Line(Teleflex)(USP#2)(White)(White/Blue)
• 08800071005124: Suture Wing All Suture Anchor '1.7' 2Line(Teleflex)(USP#2)(White)(White/Black)
• 08800071005117: Suture Wing All Suture Anchor '1.7' 1Line(Teleflex)(USP#2)(White/Blue)
• 08800071005100: Suture Wing All Suture Anchor '1.7' 1Line(Teleflex)(USP#2)(White/Black)
• 08800071005094: Suture Wing All Suture Anchor '1.7' 1Line(Teleflex)(USP#2)(Blue)
• 08800071005087: Suture Wing All Suture Anchor '1.7' 1Line(Teleflex)(USP#2)(White)