Primary Device ID | 00853799007619 |
NIH Device Record Key | d2215f62-77b7-474e-8647-2bc6bb5c2e04 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tenzing 5 |
Version Model Number | SA 2222 |
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 |
Phone | 650-350-9416 |
Customerservice@r92m.com | |
Phone | 650-350-9416 |
Customerservice@r92m.com | |
Phone | 650-350-9416 |
Customerservice@r92m.com | |
Phone | 650-350-9416 |
Customerservice@r92m.com | |
Phone | 650-350-9416 |
Customerservice@r92m.com | |
Phone | 650-350-9416 |
Customerservice@r92m.com | |
Phone | 650-350-9416 |
Customerservice@r92m.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00853799007619 [Primary] |
NRY | Catheter, Thrombus Retriever |
QJP | Catheter, Percutaneous, Neurovasculature |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-24 |
Device Publish Date | 2023-10-16 |
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 | 2023-10-24Tenzing 5 Delivery 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 | 2023-10-24 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 |