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) (2) Syringe, Antistick (MEG) (2)

Premarket Exempt

No Yes

Clear

Syringe LL, W/BioCare Safety Needle - 00858835007158 Catalog Number : BIO-1055S

Device Description : Disposable 3cc Syringe LL, W/BioGuard Safety Needle 23G x 1"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF, FMI, MEG

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00858835007165 Catalog Number : GE12006

Device Description : Disposable 1/2cc Insulin Unibody Syringe, U-100, W/Needle 30G x 5/16"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Syringe LL, W/BioCare Safety Needle - 00858835007172 Catalog Number : BIO-1063S

Device Description : Disposable 5cc Syringe LL, W/BioGuard Safety Needle 22G x 1 1/2", Each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : No

Device Count : 1

Biotronix Healthcare Syringes - 00858835007196 Catalog Number : GE12004

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

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix HealthCare Syringes - 00858835007202 Catalog Number : GE12012

Device Description : Disposable 1CC Luer Slip Syringe, W/Needle 25G x 5/8", each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix HealthCare Syringes - 00858835007219 Catalog Number : GE12010

Device Description : Disposable 1CC Luer Slip Syringe, W/Needle 27G x 1/2",Each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00858835007226 Catalog Number : GE12033

Device Description : Disposable 3CC, LL Syringe W/Needle, 21G x 1", Each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00858835007233 Catalog Number : GE12034

Device Description : Disposable 3CC, LL Syringe W/Needle, 21G x 1 1/2", Each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00858835007240 Catalog Number : GE12030

Device Description : Disposable 3CC, LL Syringe W/Neddle, 22G x 1", Each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Syringes - 00858835007257 Catalog Number : GE12032

Device Description : Disposable 3CC, LL Syringe W/Needle, 22G x 1 1/2", Each

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

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