FDA.reportPublic FDA data

Genotropin Pen® 12

Primary DI
10300132647034
Brand
Genotropin Pen® 12
Company
PHARMACIA & UPJOHN COMPANY LLC
Model
F000099111
Device description
A non-sterile, reusable pen injector designed to be used by a patient to subcutaneously inject human growth hormone using a replaceable Two-Chamber Cartridge (TCC) containing Genotropin growth hormone inserted into the device.
Published
2019-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NSCInjector, Pen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSCInjector, PenGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10300132647034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1030013264703410300132647034

GMDN Terms#

Term, Definition table
TermDefinition
Cartridge-accepting autoinjector, mechanicalA portable, hand-held, mechanical device, typically in the form of a large pen, designed to accept a pharmaceutical-containing cartridge (not included) and intended to be used by a patient to subcutaneously inject a dose of the pharmaceutical agent via a replaceable needle. The cartridge is inserted into the device and typically a dial on the device is operated for dosing (e.g., via a spring-loaded mechanism); the cartridge is replaced once the pharmaceutical is exhausted. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
484-865-6166karena.arrenon@pfizer.com
484-865-6166UDICompliance@pfizer.com

Regulatory Flags#

DUNS number
618054084
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10300134761929Genotropin Pen® 5F0001161532019-09-05
00300090297015GelfilmGelfilm® Sterile Ophthalmic Film Ophthalmic film 62015-10-22
10300090283015GelfilmGelfilm® Sterile Film Sterile film 1's (125 sq cm)2016-05-11
00300090283018GelfilmGelfilm® Sterile Film Sterile film 1's (125 sq cm)2015-10-22
00300091040016GEL-FLOW™ NTHemostatic Matrix for Flowable Applications - 6 mL2018-04-17
00300092250018GEL-FLOW KIT6 mL2018-08-17
00360793310107GELFOAM-JMI™ Sponge KitSize 1002017-06-05
00360793410104GELFOAM-JMI™ Powder Kit1 g Powder2017-06-05
10300090315082GelfoamSize 12-72014-09-01
10300090323018GelfoamSize 502014-09-01
10300090342019GelfoamSize 1002014-09-01
10300090349032GelfoamSize 2002014-09-01
10300090353015GelfoamSize 100 - Compressed2014-09-01
10300090396050GelfoamSize 4, 2 sponges per envelope2014-09-01
10300090433045Gelfoam1 g Powder2014-09-01
00300093359017Prepidil® Gel, dinoprostone cervical gelNDC 0009-3359-012020-09-24
00300090315085GelfoamSize 12-72014-09-01
00300090323011GelfoamSize 502014-09-01
00300090342012GelfoamSize 1002014-09-01
00300090349035GelfoamSize 2002014-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840164519440FOLLISTIM PEN STARTER KITOrganon LLCNSC2024-01-01
00840164519457FOLLISTIM PEN STARTER KIT SAMOrganon LLCNSC2024-01-01
60840164519442FOLLISTIM PEN STARTER KITOrganon LLCNSC2024-01-01
60840164519459FOLLISTIM PEN STARTER KIT SAMOrganon LLCNSC2024-01-01
57622436000010Omnitrope® Pen 10Sandoz Inc.NSC2023-10-05
57622436000027Omnitrope® Pen 5Sandoz Inc.NSC2023-10-05
57612799210546Omnitrope Pen 10Sandoz GmbHNSC2023-02-07
59002269207349Omnitrope Pen 5Sandoz GmbHNSC2023-02-07
47612799222856Omnitrope Pen 10Sandoz GmbHNSC2023-02-07
47612799222849Omnitrope Pen 5Sandoz GmbHNSC2023-02-07
49002269218553Omnitrope Pen 10Sandoz GmbHNSC2023-02-07
00358406480019AutoTouch Connect reusable autoinjectorAMGEN INC.NSC2021-11-08
10358406480016AutoTouch Connect reusable autoinjectorAMGEN INC.NSC2021-11-08
00015482272531Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 100'sARKRAY USA, INC.NSC2020-01-21
00015482272838Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 100'sARKRAY USA, INC.NSC2020-01-21
00015482273538Assure® ID DUO-Shield Safety Pen Needle 5mm x 30g 10'sARKRAY USA, INC.NSC2020-01-21
00015482273835Assure® ID DUO-Shield Safety Pen Needle 8mm x 30g 10'sARKRAY USA, INC.NSC2020-01-21
00300520311540FOLLISTIM PEN STARTER KIT USAMerck Sharp & Dohme LLCNSC2019-11-14
60300520311542FOLLISTIM PEN STARTER KIT USAMERCK SHARP & DOHME CORP.NSC2019-11-14
00300520311533FOLLISTIM PEN STARTER KIT SAM USAMerck Sharp & Dohme LLCNSC2019-10-28
60300520311535FOLLISTIM PEN STARTER KIT SAM USAMERCK SHARP & DOHME CORP.NSC2019-10-28
00355513192019Onpro kitAMGEN INC.NSC2019-09-24
00358406470010AutoTouch reusable autoinjectorAMGEN INC.NSC2019-09-24
10358406470017AutoTouch reusable autoinjectorAMGEN INC.NSC2019-09-24
10300134761929Genotropin Pen® 5PHARMACIA & UPJOHN COMPANY LLCNSC2019-09-05