SINEFIX 30001

GUDID 08720629950471

Rotator cuff repair device

Baat Medical Products B.V.

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 08720629950471
• NIH Device Record Key: 9ad9356f-6003-44a9-971a-8316ab468108
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SINEFIX
• Version Model Number: SINEFIX
• Catalog Number: 30001
• Company DUNS: 413205480
• Company Name: Baat Medical Products B.V.
• 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	08720629950464 [Primary]
GS1	08720629950471 [Package]; Contains: 08720629950464; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220966

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: 2023-04-19
• Device Publish Date: 2023-04-11

On-Brand Devices [SINEFIX]

• 08720629950549: Tray
• 08720629950532: Repusher
• 08720629950525: Trocar
• 08720629950518: Stop clip
• 08720629950501: Lateral anchor inserter
• 08720629950495: Medial anchor inserter
• 08720629950488: Base plate inserter
• 08720629950471: Rotator cuff repair device
• 08720629959214: SINEFIX Instrument Tray
• 08720629959207: Repusher
• 08720629959191: Lateral Driver
• 08720629959184: Medial Driver
• 08720629959177: SINEFIX Easy Grip