DEVICE: PRIORITYONE (04543334177254)

Device Identifier (DI) Information

PRIORITYONE
30-6100
In Commercial Distribution
UG1602
TERUMO CLINICAL SUPPLY CO., LTD.
04543334177254
GS1

1
691034748 *Terms of Use
PRIORITYONE Aspiration Catheter
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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
Thrombectomy suction catheter A sterile flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
DXE Catheter, Embolectomy
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K112382 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Fragile. Keep dry. Keep away from sunlight.
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Clinically Relevant Size

[?]
Size Type Text
Length: 140 Centimeter
Device Size Text, specify: Min. Guide Catheter I.D. 1.78Millimeter
Device Size Text, specify: Min. Guide Catheter I.D. 0.070Inch
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Device Record Status

6e94e7ab-b528-4d20-a2c9-41818327dd38
July 06, 2018
3
September 16, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
54543334177259 5 04543334177254 In Commercial Distribution Carton
74543334177253 2 54543334177259 In Commercial Distribution Carton
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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