FDA.reportPublic FDA data

PowrSyringe

Primary DI
B090PWR100
Brand
PowrSyringe
Company
Zien Medical Technologies, LLC
Model
PWR-10
Device description
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.
Published
2022-08-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072318000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072318000POWRSYRINGE INJECTORPinyons Medical Technology, Inc.2007-09-21FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B090PWR101PackageHIBCC1Not in Commercial Distribution
B090PWR102PackageHIBCC10Not in Commercial Distribution
B090PWR100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Angiographic syringeA 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.

Regulatory Flags#

DUNS number
017535668
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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B090A110900Control 11F Mechanical Thrombectomy SystemA11-090A11-0902022-06-29
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B090A70900Control 7F Mechanical Thrombectomy SystemA7-090A7-0902022-06-29
B090A90600Control 9F Mechanical Thrombectomy System, 60cmA9-060A9-0602022-06-29
B090A90900Control 9F Mechanical Thrombectomy System, 90cmA9-090A9-0902022-06-29
B090ARXLP60Control RX-LP Mechanical Thrombectomy System, 136cmARX-LP6ARX-LP62017-08-17
B090ASP10010Control RX-LP Mechanical Thrombectomy SystemASP-1001ASP-10012023-04-26
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Primary DI, Brand, Company table
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