DEVICE: FINECROSS (04987350703163)

Download: XML | JSON

Device Identifier (DI) Information

FINECROSS
35-1430
NC*F863A
TERUMO CORPORATION
04987350703163
GS1
1
FINECROSS MG Coronary Micro-Guide Catheter
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Vascular guide-catheter, single-use A sterile, flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. This is a single-use device.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KRA Catheter, continuous flush
CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Fragile. Keep dry. Keep away from sunlight. Stacking limit by 10.
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 0.60 Millimeter
Device Size Text, specify: Clinically Relevant Size 1 is relative to the catheter distal end. And Clinically Relevant Size 2 is relative to the catheter proximal shaft.
Length: 130 Centimeter
CLOSE

Device Status

In Commercial Distribution
September 09, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
54987350703168 5 04987350703163 In Commercial Distribution Carton
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)283-7866
tmccustomer.admin@terumomedical.com
CLOSE