BIOTRONIX HEALTHCARE INDUSTRIES, INC.

Address:4720 Salisbury Road,Jacksonville,FL,32256,US

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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

Syringe, Piston (FMF) (10) Needle, Hypodermic, Single Lumen (FMI) (6) Syringe, Antistick (MEG) (5)

Premarket Exempt

No Yes

Clear

Biotronix Healthcare Syringes - 00858835007363 Catalog Number : GE12007

Device Description : Disposable 1/2CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16", 10/Bag

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00858835007370 Catalog Number : GE12011

Device Description : Disposable .30CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16", 10/Bag

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00858835007400 Catalog Number :

Device Description : Disposable 1CC Insulin Unibody Syringe, U-100, Needle 31G x 5/16"

Device Class :

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Syringe LL, W/BioCare Safety Needle - 00858835007431 Catalog Number : BIO-1067S

Device Description : Disposable 10cc Syringe LL, W/BioGuard Safety Needle 21G x 1 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

Syringe LS, W/ BioCare Safety Needle - 00858835007738 Catalog Number : BIO-T-1047

Device Description : Disposable 1cc LS, Tuberculin Syringe W/BioGuard Safety Needle 27G x 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

Syringe LL, W/BioCare Safety Needle - 00858835007745 Catalog Number : GE1061S

Device Description : Disposable 5cc Syringe LL, W/BioGuard Safety Needle 21G x 1 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

BioCare Safety Needles - 00858835007752 Catalog Number :

Device Description : Disposable BioGuard Safety Needles 20G x 1 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

BioCare Safety Needles - 00858835007769 Catalog Number : BIO-1021S

Device Description : Disposable BioGuard Safety Needles 21G x 1 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

BioCare Safety Needles - 00858835007776 Catalog Number : BIO-10231S

Device Description : Disposable BioGuard Safety Needles 23G x 1 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00858835007783 Catalog Number : GE12026

Device Description : 30cc Luer Lock Syringe W/O Needle, Each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

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