Tenzing 7 Delivery Catheter REF 1005

GUDID 00853799007237

Tenzing 7 Delivery Catheter

ROUTE 92 MEDICAL

Vascular microcatheter

• Primary Device ID: 00853799007237
• NIH Device Record Key: f7b6776c-d362-4877-b2a5-5de6edac607f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tenzing 7 Delivery Catheter
• Version Model Number: FD 0475
• Catalog Number: REF 1005
• Company DUNS: 067429673
• Company Name: ROUTE 92 MEDICAL
• 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: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com
• Phone: 650-350-9416
• Email: Customerservice@r92m.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853799007237 [Primary]
GS1	00853799007244 [Package]; Package: Shelf Carton [1 Units]; In Commercial Distribution
GS1	00853799007442 [Package]; Package: Shelf-Carton [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190431

FDA Product Code

• DQY: Catheter, Percutaneous

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: 2020-09-25
• Device Publish Date: 2020-09-17

On-Brand Devices [Tenzing 7 Delivery Catheter]

• 00853799007237: Tenzing 7 Delivery Catheter
• 00853799007541: Tenzing 7 Delivery Catheter
• 00853799007534: Tenzing 7 Delivery Catheter; Contains Tenzing 7 Delivery Catheter (00853799007541)