OptEase Retrieval Catheter 466C220F

GUDID 20705032009376

CORDIS CORPORATION

Intravascular catheter-snare Intravascular catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare Intravascular extraction catheter-snare

• Primary Device ID: 20705032009376
• NIH Device Record Key: b4a71ecb-0404-4d94-bca7-534c8ab2c40d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OptEase Retrieval Catheter
• Version Model Number: 466C220F
• Catalog Number: 466C220F
• Company DUNS: 806136177
• Company Name: CORDIS CORPORATION
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.
• Special Storage Condition, Specify: Between 0 and 0 *Do not use open or damaged packages
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dark, dry place.

Device Identifiers

Device Issuing Agency	Device ID
GS1	20705032009376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140286

FDA Product Code

• DTK: FILTER, INTRAVASCULAR, CARDIOVASCULAR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-08-28

Devices Manufactured by CORDIS CORPORATION

• 20705032026335 - SUPERTORQUE PLUS: 2024-03-22 MULTIPAC ST+ 6 JL4,ARI,PIG,CSI,GW
• 20705032026342 - SUPERTORQUE PLUS: 2024-03-22 MULTIPAC ST+ 6 JL4,ARI,PIG145,CSI,GW
• 20705032045534 - SUPERTORQUE PLUS: 2024-03-22 6F ST+ .038 125CM JL6
• 20705032049235 - SUPERTORQUE: 2024-03-22 6F ST 0.038 100CM 2SH MPB2
• 20705032049891 - SUPERTORQUE: 2024-03-22 6F ST 0.038” 80CM 4SH CAS3
• 20705032051641 - SUPERTORQUE: 2024-03-22 6 F ST 0.038" 65CM MPA
• 20705032063064 - SUPERTORQUE PLUS: 2024-03-22 CATHETER F6ST+ 100CM
• 20705032063286 - SUPERTORQUE: 2024-03-22 5.2 F ST 0.038 90CM SPINAL