EMD SERONO, INC.

Address:ONE TECHNOLOGY PLACE,ROCKLAND,MA,02370,US

Want to know more about this Organization? Request more information now!

Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Needle, Hypodermic, Single Lumen (FMI) (2) Introducer, Syringe Needle (KZH) (1) Syringe, Piston (FMF) (1)

Premarket Exempt

Clear

one.click needle - 04046963412791 Catalog Number : 16440EMD

Device Description : Needles for one.click® auto-injector. Single packed, sterile. For single use onl Needles for one.click® auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.

Device Class :

Duns Number: 088514898

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

Serofine needles 29 G - 04046963413873 Catalog Number : 16441EMD

Device Description : Needles for easypod auto-injector. Single packed, sterile. For single use only. Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.

Device Class :

Duns Number: 088514898

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 100

Serofine needles 30G - 04046963414030 Catalog Number : 16442EMD

Device Description : Needles for easypod auto-injector. Single packed, sterile. For single use only. Needles for easypod auto-injector. Single packed, sterile. For single use only. Non-pyrogenic.

Device Class :

Duns Number: 088514898

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 100

Pencylcap needle - 04046964756290 Catalog Number : P1400063

Device Description : Needles for use with compatible needle-based injection systems for subcutaneousi Needles for use with compatible needle-based injection systems for subcutaneousinjection of fluid drug products. Single packed, sterile. For single use only.Non-pyrogenic.

Device Class :

Duns Number: 088514898

Premarket Exempt : No

Product Code : FMI

Prescription Use : Yes

Device Count : 100

one.click - 04054839025792 Catalog Number :

Device Description : one.click is a mechanical auto-injector which automatically administers a pre-se one.click is a mechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rNDA origin]) in cartridges.

Device Class :

Duns Number: 088514898

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Rebiject II - 04054839025808 Catalog Number :

Device Description : Rebiject II® autoinjector is a device intended for automating subcutaneous injec Rebiject II® autoinjector is a device intended for automating subcutaneous injection of Rebif® (interferon beta-1a) in pre-filled glass syringes.

Device Class : 2

Duns Number: 088514898

Premarket Exempt : No

Product Code : KZH

Prescription Use : Yes

Device Count : 1

easypod - 04054839025860 Catalog Number :

Device Description : easypod is an electromechanical auto-injector which automatically administers a easypod is an electromechanical auto-injector which automatically administers a pre-set dose of Saizen (somatropin [rDNA origin]) in cartridges.

Device Class :

Duns Number: 088514898

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Clip-on Spacers for Rebif - 04054839025914 Catalog Number :

Device Description : Titration Clip for Dose Titration using Rebif® 22 mcg or 44 mcg Pre-filled Syringe.

Device Class : 2

Duns Number: 088514898

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Previous 1 Next