CEREPAK FREEFORM MCR092060

GUDID 10886704083016

CEREPAK FREEFORM Mini Detachable Coil Delivery System Length - 190 cm Coil Diameter - 2 mm Coil Length - 6 cm

Medos International Sàrl

Neurovascular embolization coil

• Primary Device ID: 10886704083016
• NIH Device Record Key: a8fd2f54-e332-4e44-8c35-f14611a7f813
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CEREPAK FREEFORM
• Version Model Number: MCR092060
• Catalog Number: MCR092060
• Company DUNS: 482661753
• Company Name: Medos International Sàrl
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886704083016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220040

FDA Product Code

• KRD: Device, Vascular, for Promoting Embolization

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-24
• Device Publish Date: 2022-09-15

Devices Manufactured by Medos International Sàrl

• 10886705001163 - VERSALOK: 2025-05-08 Versalok Anchor with Threader Tab
• 10886705032952 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN BR Anchor w/ DYNACORD and Needles
• 10886705032969 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN BR Anchor_x000D_ w/ Dual Strand DYNACORD and Needles
• 10886705032976 - GRYPHON X: 2025-04-30 GRYPHON X THREADED BR Anchor_x000D_ w/ DYNACORD and Needles
• 10886705032983 - GRYPHON X: 2025-04-30 GRYPHON X THREADED BR Anchor _x000D_ w/ Dual Strand DYNACORD and Needles
• 10886705032990 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN PEEK Anchor _x000D_ w/ DYNACORD and Needles
• 10886705033003 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN PEEK Anchor _x000D_ w/ Dual Strand DYNACORD and Needles
• 10886705033010 - GRYPHON X: 2025-04-30 GRYPHON X PUSH-IN BR Anchor _x000D_ w/ 1.3mm PERMATAPE and Needles