FDA.reportPublic FDA data

Stratis®

Primary DI
00856457003206
Brand
Stratis®
Company
PHARMAJET, INC.
Model
C501-10
Catalog number
C501-10
Device description
0.5mL Stratis® Injector
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KZEInjector, Fluid, Non-Electrically Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZEInjector, Fluid, Non-Electrically PoweredGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111517000PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIPharmajet, Inc.2011-07-27KZE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856457003203PackageGS110In Commercial Distribution
00856457003206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085645700320310856457003203
00856457003206008564570032068564570032060856457003206

GMDN Terms#

Term, Definition table
TermDefinition
Needleless medication/vaccine injector, mechanicalA hand-held, mechanically-powered (e.g., spring-powered) device designed to inject medication (especially a local anaesthetic, vaccine or medication) transcutaneously into the human body. It is a manually-operated, needleless device that can have various configurations according to application. It will typically be a pistol-shaped plunger driven instrument with single or multi-pointed holed barrels through which the medication/vaccine is driven under high pressure. The delivered medication/vaccine will typically be supplied in prefilled containers. This device is not a hypodermic syringe. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
609816892
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856457003329Stratis®C501-43C501-432016-09-19
00856457003336Stratis®C501-46C501-462016-09-19
00856457003213Stratis®C501-20C501-202016-09-19
00856457003305Stratis®C501-32C501-322016-09-19
00856457003312Stratis®C501-34C501-342016-09-19
00856457003367Stratis®C501-43C501-432016-09-19
00856457003374Stratis®C501-46C501-462016-09-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199284222250Robbins Dermo-jetRobbins Instruments Inc.KZE2025-08-22
07290016746754Treatment Kit 2.0VIORA LTDKZE2025-06-03
07290016746761Treatment Kit 2.0VIORA LTDKZE2025-06-03
07290016746716ConsoleVIORA LTDKZE2025-05-22
07290016746723ApplicatorVIORA LTDKZE2025-05-22
07290016746730TrolleyVIORA LTDKZE2025-05-22
07290016746747Disposable Delivery NozzleVIORA LTDKZE2025-05-22
B07281641001J-TipNATIONAL MEDICAL PRODUCTS, INC.KZE2024-05-27
B07281642001J-TipNATIONAL MEDICAL PRODUCTS, INC.KZE2024-05-27
07290017151007AirGent-2.0PERFACTION TECHNOLOGIES LTDKZE2018-12-18
07640180261018ZOMA-JetFERRING PHARMACEUTICALS INC.KZE2018-08-01
07640180261001ZOMA-JetFERRING PHARMACEUTICALS INC.KZE2018-08-01
00856457003329Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003336Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003213Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003305Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003312Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003367Stratis®PHARMAJET, INC.KZE2016-09-19
00856457003374Stratis®PHARMAJET, INC.KZE2016-09-19