ENDOPEARL C8058

GUDID 20845854013776

ENDOPEARL 8MM, SOFT TISSUE FIXATION DEVICE

Conmed Corporation

Tendon/ligament bone anchor, bioabsorbable

• Primary Device ID: 20845854013776
• NIH Device Record Key: d207a0d8-297a-4088-bdd1-f735ec634162
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENDOPEARL
• Version Model Number: C8058
• Catalog Number: C8058
• Company DUNS: 071595540
• Company Name: Conmed 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(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM
• Phone: +1(800)237-0169
• Email: CUSTOMER_SERVICE@CONMED.COM

Device Dimensions

• Outer Diameter: 8 Millimeter
• Outer Diameter: 8 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY
• Special Storage Condition, Specify: Between 0 and 0 *KEEP DRY

Device Identifiers

Device Issuing Agency	Device ID
GS1	20845854013776 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984171

FDA Product Code

• MAI: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Sterilization

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

[20845854013776]

Ethylene Oxide

[20845854013776]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-21
• Device Publish Date: 2016-09-24

On-Brand Devices [ENDOPEARL]

• 20845854014292: ENDOPEARL 7MM, SOFT TISSUE FIXATION DEVICE
• 20845854013776: ENDOPEARL 8MM, SOFT TISSUE FIXATION DEVICE
• 20845854013578: ENDOPEARL 9MM, SOFT TISSUE FIXATION DEVICE