3910-100-035

GUDID 37613154015307

5MM CUFF ANCHOR WITH 2 STRANDS #2 FORCE FIBER, 2 CHANNELS

STRYKER CORPORATION

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 37613154015307
• NIH Device Record Key: 95cc6fea-e631-4551-b494-fdea830d5371
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 3910-100-035
• Catalog Number: 3910-100-035
• Company DUNS: 187502109
• Company Name: STRYKER CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Customer Support Contacts

• Phone: +1(866)624-4422
• Email: xx@xx.xx

Device Dimensions

• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154015306 [Primary]
GS1	37613154015307 [Package]; Contains: 07613154015306; Package: pack [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041310

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: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-09-04

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