DEVICE: NAVICROSS (04987350709202)
Device Identifier (DI) Information
NAVICROSS
NC35131
In Commercial Distribution
WS*NA350N3H
TERUMO CORPORATION
NC35131
In Commercial Distribution
WS*NA350N3H
TERUMO CORPORATION
NAVICROSS Support Catheter
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
17846 | Vascular guide-catheter, single-use |
A flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DQY | CATHETER, PERCUTANEOUS |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10. |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 1.39 Millimeter |
Device Size Text, specify: Tip shape : Angled |
Device Size Text, specify: Max Guide Wire O.D. : 0.035" (0.89mm) |
Pressure: 5171 KiloPascal |
Length: 135 Centimeter |
Device Record Status
d6c7e5b3-a715-4892-915c-299067d3142c
December 22, 2021
6
September 09, 2016
December 22, 2021
6
September 09, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
54987350709207 | 5 | 04987350709202 | In Commercial Distribution | Carton |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
tmccustomer.admin@terumomedical.com