LUPINE ORTHOCORD 222980

GUDID 10886705008582

LUPINE LOOP ANCHOR Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braided Composite Suture, 36 Inches (91cm). Size 2 (5 metric) ORTHOCORD eyelet loop.

DEPUY MITEK, LLC

Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10886705008582
• NIH Device Record Key: 5115c24d-20fa-4134-aee1-db21d84f1c87
• Commercial Distribution Discontinuation: 2021-01-28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUPINE ORTHOCORD
• Version Model Number: 222980
• Catalog Number: 222980
• Company DUNS: 190572854
• Company Name: DEPUY MITEK, LLC
• 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(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx
• Phone: +1(800)255-2500
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 and 26 Degrees Celsius
• Storage Environment Temperature: Between 0 and 26 Degrees Celsius
• Handling Environment Temperature: Between 0 and 80 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705008582 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040827

FDA Product Code

• GAM: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2021-01-07
• Device Publish Date: 2015-09-01

On-Brand Devices [LUPINE ORTHOCORD]

• 10886705008599: LUPINE Loop Dual Suture (DS) Anchor PLA Absorbable Anchor, with two size 2 (5 metric) ORTHOCORD
• 10886705008582: LUPINE LOOP ANCHOR Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet ORTHOCORD Braide
• 10886705001071: LUPINE Loop PLUS Dual Suture (DS) Anchor w/ORTHOCORD PLA Absorbable Anchor, with two size 2 (5 m
• 10886705001064: LUPINE Loop Plus Anchor w/ORTHOCORD Poly Lactic Acid Absorbable Anchor, size 2 (5 metric) violet