REELX 3910-600-060

GUDID 37613252017579

5.5MM STRYKER REELX STT ANCHOR

STRYKER CORPORATION

Tendon/ligament bone anchor, non-bioabsorbable

• Primary Device ID: 37613252017579
• NIH Device Record Key: 7b1fe24c-750e-4c27-a1f6-d918825f3ffe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REELX
• Version Model Number: 3910-600-060
• Catalog Number: 3910-600-060
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 54 Degrees Celsius
• Handling Environment Temperature: Between 0 and 54 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252017578 [Primary]
GS1	37613252017579 [Package]; Contains: 07613252017578; Package: pack [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090530

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

On-Brand Devices [REELX]

• 37613252592809: 4.5MM STRYKER REELX STT ANCHOR
• 37613252017579: 5.5MM STRYKER REELX STT ANCHOR