DEVICE: PROGREAT (04987350771797)
Device Identifier (DI) Information
PROGREAT
MC*PE28111YB
In Commercial Distribution
MC*PE28111YB
TERUMO CORPORATION
MC*PE28111YB
In Commercial Distribution
MC*PE28111YB
TERUMO CORPORATION
PROGREAT Microcatheter Coaxial System
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
10691 | Vascular microcatheter |
A sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KRA | Catheter, continuous flush |
DQO | CATHETER, INTRAVASCULAR, DIAGNOSTIC |
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 |
---|
Device Size Text, specify: Clinically Relevant Size 1 is relative to catheter distal end. And other Clinically Relevant Sizes are relative to catheter shaft. |
Outer Diameter: 0.93 Millimeter |
Length: 110 Centimeter |
Device Record Status
ecb9060f-2db4-4bde-a389-e9990e3df864
March 21, 2019
3
September 09, 2016
March 21, 2019
3
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 |
---|---|---|---|---|---|
54987350771792 | 5 | 04987350771797 | 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