FDA.reportPublic FDA data

MADA MEDICAL PRODUCTS, INC.

Primary DI
00815160020627
Brand
MADA MEDICAL PRODUCTS, INC.
Company
MADA MEDICAL PRODUCTS, INC
Model
401
Catalog number
401
Device description
.A 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.
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGMInjector, Jet, Mechanical-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGMInjector, Jet, Mechanical-PoweredDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815160020627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815160020627008151600206278151600206270815160020627

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

Contacts#

Phone, Email table
PhoneEmail
(201)460-0454dianelind@madamedical.com

Regulatory Flags#

DUNS number
048411862
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815160020573MADA MEDICAL PRODUCTS,INC.2772772018-08-20
00815160020597MADA MEDICAL PRODUCTS,INC.277-220V277-220V2018-08-20
00815160021310MADA MEDICAL PRODUCTS, INC.R1836GBHF-25GPR1836GBHF-25GP2024-04-22
00815160021129MADA MEDICAL PRODUCTS, INC.7000-MVP7000-MVP2023-06-27
00815160020498MADA MEDICAL PRODUCTS, INC.1301M1301M2023-09-02
00815160020504MADA MEDICAL PRODUCTS, INC.1301ME1301ME2023-09-02
00815160021280MADA MEDICAL PRODUCTS, INC.R1835-25GBHF-25R1835-25GBHF-252023-09-02
00815160021297MADA MEDICAL PRODUCTS, INC.1415MS1415MS2023-09-02
00815160021303MADA MEDICAL PRODUCTS, INC.1529E1529E2023-09-02
00815160021327MADA MEDICAL PRODUCTS, INC.1515A-151515A-152023-09-02
00815160021334MADA MEDICAL PRODUCTS, INC.1630-151630-152023-09-02
00815160021341MADA MEDICAL PRODUCTS, INC.1630-A151630-A152023-09-02
00815160021358MADA MEDICAL PRODUCTS, INC.1630A-15E1630A-15E2023-09-02
00815160021365MADA MEDICAL PRODUCTS, INC.163016302023-09-02
00815160021372MADA MEDICAL PRODUCTS, INC.1616-15E1616-15E2023-09-02
00815160021389MADA MEDICAL PRODUCTS, INC.1630M-15E1630M=15E2023-09-02
00815160021396MADA MEDICAL PRODUCTS, INC.1616-AE1616-AE2023-09-02
00815160021235MADA MEDICAL PRODUCTS, INC.1701-A1701-A2023-08-05
00815160021242MADA MEDICAL PRODUCTS, INC.1701-81701-82023-08-05
00815160021259MADA MEDICAL PRODUCTS, INC.135913592023-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760349801054QUICKSLEEPER 5C_A2 US/CADENTALHITECEGM2025-12-22
05713513000058PAROJECTRønvig Dental Manufacturing A/SEGM2017-08-25
00815160020580MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020610MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020634MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020641MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00815160020658MADA MEDICAL PRODUCTS, INC.MADA MEDICAL PRODUCTS, INCEGM2016-09-19
00303620000024PAROJECTSEPTODONT, INCEGM2016-09-15
00303620000031PLUNGER FOR PAROJECT-HF02500A1SEPTODONT, INCEGM2016-09-15