FDA.reportPublic FDA data

Stratis®

Primary DI
00856457003213
Brand
Stratis®
Company
PHARMAJET, INC.
Model
C501-20
Catalog number
C501-20
Device description
0.5mL Stratis® Reset Station
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
10856457003210PackageGS110In Commercial Distribution
00856457003213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085645700321010856457003210
00856457003213008564570032138564570032130856457003213

GMDN Terms#

Term, Definition table
TermDefinition
Injector reset deviceA device designed to be used by a layperson (this usually being the recipient of the injection) to reset the loaded position of an injector in a safe and controlled manner. It will typically be designed like a small box or container and have a hinged lid. The injector is placed inside this device and when the lid is closed an internal mechanism resets the injector to its firing position. The injector is removed from this device, the medication is inserted (typically a prefilled syringe or cartridge) and it is ready for use by the user. 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
00856457003206Stratis®C501-10C501-102016-09-19
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
00856457003206Stratis®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