PANALOK ETHIBOND 210025

GUDID 10886705000807

PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 Inches (91cm), double-armed with CP-2 needles, with disposable inserter.

DEPUY MITEK, LLC

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 10886705000807
• NIH Device Record Key: 4657c2b1-7881-4259-b170-0fd9c7bb8edc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PANALOK ETHIBOND
• Version Model Number: 210025
• Catalog Number: 210025
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705000807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150209

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: 5
• Public Version Date: 2025-02-17
• Device Publish Date: 2015-09-01

On-Brand Devices [PANALOK ETHIBOND]

• 10886705000814: PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) white ETHIBOND braided polyester suture, 36 In
• 10886705000807: PANALOK Absorbable Anchor 3.5mm Size 2 (5 metric) green ETHIBOND braided polyester suture, 36 In