RAPIDLOC PDS PANACRYL 228311

GUDID 10886705010196

RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 12 Degrees Absorbable - PLA/PDS with Size 2/0 (3 metric) PANACRYL braided absorbable suture, and 12 Degrees curved needle

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

• Primary Device ID: 10886705010196
• NIH Device Record Key: bf261aa0-15f3-41fd-b804-9401a2128e8d
• Commercial Distribution Discontinuation: 2021-01-28
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAPIDLOC PDS PANACRYL
• Version Model Number: 228311
• Catalog Number: 228311
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886705010196 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023388

FDA Product Code

• JDR: STAPLE, FIXATION, BONE

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 [RAPIDLOC PDS PANACRYL]

• 10886705010202: RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 27 Degrees Absorbable - PLA/PDS with Size 2/0 (3 metric) P
• 10886705010196: RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 12 Degrees Absorbable - PLA/PDS with Size 2/0 (3 metric) P
• 10886705010189: RAPIDLOC PDS MENISCAL REPAIR SYSTEM / 0 Degrees Absorbable - PLA/PDS with Size 2/0 (3 metric) PA