Biozip 3910-200-025

GUDID 37613154019862

5MM BIOZIP W/O NEEDLES, 2 STRANDS #2 FORCE FIBER

STRYKER CORPORATION

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 37613154019862
• NIH Device Record Key: 8762efb0-220c-4280-a802-19bb7c8da121
• Commercial Distribution Discontinuation: 2018-12-07
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Biozip
• Version Model Number: 3910-200-025
• Catalog Number: 3910-200-025
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154019861 [Primary]
GS1	37613154019862 [Package]; Contains: 07613154019861; Package: pack [5 Units]; Discontinued: 2018-12-07; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041305

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: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-03-21
• Device Publish Date: 2015-09-09

On-Brand Devices [Biozip]

• 37613154470892: 6.5MM BIOZIP W/O NEEDLES 2 STRANDS #2 FORCE FIBER
• 37613154470885: 6.5MM BIOZIP WITH ¿ CIRCLE TAPER NEEDLES, 2 STRANDS #2 BRAIDED POLYESTER
• 37613154019862: 5MM BIOZIP W/O NEEDLES, 2 STRANDS #2 FORCE FIBER
• 34546540392467: 5MM BIOZIP WITH ¿ CIRCLE TAPER NEEDLES, 2 STRANDS #2 BRAIDED POLYESTER
• 04546540392435: 6.5MM BIOZIP DRILL 4.0MM X 13.5MM
• 04546540392428: 5.0MM BIOZIP DRILL 3.25MM X 13.5MM
• 04546540392398: AWL, 6.5 MM BIOZIP ANCHOR
• 04546540392381: AWL, 5.0MM BIOZIP ANCHOR