PowrSyringe

GUDID B090PWR101

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.

ZIEN MEDICAL TECHNOLOGIES, INC.

Angiographic syringe
Primary Device IDB090PWR101
NIH Device Record Key4f2449e2-f213-46eb-8355-97355ad268f6
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowrSyringe
Version Model NumberPWR-10
Company DUNS017535668
Company NameZIEN MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB090PWR100 [Primary]
HIBCCB090PWR101 [Package]
Contains: B090PWR100
Package: Shelf Carton [1 Units]
In Commercial Distribution
HIBCCB090PWR102 [Package]
Package: Shipper [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FMFSyringe, Piston

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-31
Device Publish Date2022-08-23

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

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