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

Bandage, Cast (ITG) (4) Needle, Hypodermic, Single Lumen (FMI) (4) Syringe, Piston (FMF) (4) Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days (FOZ) (2) Syringe, Antistick (MEG) (2)

Premarket Exempt

No Yes

Clear

Bio-Gaurd Safety Needles - 00858835007790 Catalog Number : BIO-1011S

Device Description : Disposable Bio-Gaurd Safety Needles 18G x 1"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : Yes

Device Count : 1

1cc Insulin Syringe w/ Bio-Guard Safety Needle - 00858835007806 Catalog Number : BIO-IN-1001

Device Description : 1cc Luer Lock Insulin Syringe w/ Bio-Guard Safety Needle 30G x 1/2"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

Bio-Guard Safety Needles - 00858835007813 Catalog Number : BIO-1022S

Device Description : Disposable Bio-Gaurd Safety Needles 22G x 1"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF

Prescription Use : Yes

Device Count : 1

Bio-Guard Safety Needles - 00858835007820 Catalog Number : BIO-1025S

Device Description : Disposable Bio-Gaurd Safety Needles 25G x 5/8"

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FMI, FMF, MEG

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Cotton Cast Padding - 00858835007868 Catalog Number : PO2001

Device Description : Cotton Cast Padding, 2" x 4.1yds, 24 Rolls/Bag

Device Class : 1

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Cotton Cast Padding - 00858835007882 Catalog Number : PO2002

Device Description : Cotton Cast Padding, 3" x 4.1yds, 12 Rolls/Bag

Device Class : 1

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Cotton Cast Padding - 00858835007899 Catalog Number : PO2003

Device Description : Cotton Cast Padding, 4" x 4.1yds, 12 Rolls/Bag,

Device Class :

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare Cotton Cast Padding - 00858835007905 Catalog Number : PO2004

Device Description : Cotton Cast Padding, 6" x 4.1yds, 12 Rolls/Bag

Device Class : 1

Duns Number: 065762392

Premarket Exempt : Yes

Product Code : ITG

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare IV Catheters - 00858835007912 Catalog Number :

Device Description : Disposable I.V. Catheter 18G x 1.25" Green

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

Biotronix Healthcare IV Catheters - 00858835007929 Catalog Number :

Device Description : IV CATHETER 20G X 1 1/4" PINK,

Device Class : 2

Duns Number: 065762392

Premarket Exempt : No

Product Code : FOZ

Prescription Use : Yes

Device Count : 1

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