DEVICE: PowrSyringe (B090PWR100)
Device Identifier (DI) Information
PowrSyringe
PWR-10
In Commercial Distribution
ZIEN MEDICAL TECHNOLOGIES, INC.
PWR-10
In Commercial Distribution
ZIEN MEDICAL TECHNOLOGIES, INC.
The PowrSyringe is a disposable, hand-held, 10mL injection syringe that incorporates ergonomic and mechanical advantages for fluid injection in a variety of medical procedures.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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15286 | Angiographic syringe |
A sterile, manually-operated device consisting of a barrel (cylinder) with plunger intended to be used for the administration of a contrast medium into the heart, great vessels, and coronary arteries to study the heart and vessels under x-ray photography. It may in addition be intended for introduction of other fluids (e.g., saline). It is not intended to be used with a contrast medium injection system. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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FMF | Syringe, Piston |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K072318 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
4f2449e2-f213-46eb-8355-97355ad268f6
August 31, 2022
1
August 23, 2022
August 31, 2022
1
August 23, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B090PWR101 | 1 | B090PWR100 | In Commercial Distribution | Shelf Carton | |
B090PWR102 | 10 | B090PWR101 | In Commercial Distribution | Shipper |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined