FreeClimb 54, 125cm

GUDID 00853799007657

FreeClimb 54 Catheter, 125cm

ROUTE 92 MEDICAL

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• Primary Device ID: 00853799007657
• NIH Device Record Key: dc6aa74c-6804-4a9f-8cf8-6b3a1298e96a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeClimb 54, 125cm
• Version Model Number: SA 2426
• Company DUNS: 067429673
• Company Name: ROUTE 92 MEDICAL
• Device Count: 1
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853799007633 [Primary]
GS1	00853799007657 [Package]; Contains: 00853799007633; Package: Shelf-Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231583

FDA Product Code

• QJP: Catheter, Percutaneous, Neurovasculature

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-24
• Device Publish Date: 2023-10-16

Devices Manufactured by ROUTE 92 MEDICAL

• 00853799007626 - FreeClimb 54 x 148 cm Catheter: 2024-05-20 FreeClimb 54 x 148 cm Catheter
• 00853799007633 - FreeClimb 54 x 125 cm Catheter: 2024-05-20 FreeClimb 54 x 125 cm Catheter
• 00853799007619 - Tenzing 5: 2023-10-24 Tenzing 5 Delivery Catheter
• 00853799007640 - FreeClimb 54, 148cm: 2023-10-24 FreeClimb 54 Catheter, 148cm
• 00853799007657 - FreeClimb 54, 125cm: 2023-10-24FreeClimb 54 Catheter, 125cm
• 00853799007657 - FreeClimb 54, 125cm: 2023-10-24 FreeClimb 54 Catheter, 125cm
• 00853799007183 - FreeClimb 70: 2023-05-03 Full Length 070 Catheter
• 00853799007060 - Full Length 088 Catheter, 132 cm: 2022-06-30 Full Length 088 Catheter, 132 cm
• 00853799007138 - Full Length 088 x 132cm Access System: 2022-06-30 Full Length 088 x 132cm Access System; Contains Tenzing 8 Delivery Catheter (00853799007299) and Full Length 088 Catheter, 132cm