REMINGTON MEDICAL, INC.

Address:6830 Meadowridge Ct,ALPHARETTA,GA,30005,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

NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE (GAA) (5) INSTRUMENTS, SURGICAL, CARDIOVASCULAR (DWS) (4) INTRODUCER, CATHETER (DYB) (1)

Premarket Exempt

No Yes

Clear

Disposable Tear-Away Vascular Introducer Set - 00813079020219 Catalog Number : 7011

Device Description : 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syring 1 - Dilator/Tear-Away Sheath Assembly, 1 - 18-Gauge XTW Needle, 1 - 12 cc Syringe and 1 - 0.038 in. x 50 cm Guide Wire

Device Class : 2

Duns Number: 788472314

Premarket Exempt : No

Product Code : DYB

Prescription Use : Yes

Device Count : 1

Bone Marrow "I" Needle - 00813079020226 Catalog Number : 1501-I

Device Description : 15ga (1.8mm) x 1 7/8" (5cm)

Device Class :

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Bone Marrow "I" Needle - 00813079020233 Catalog Number : 1601-I

Device Description : 16ga (1.7mm) x 1 7/8" (5cm)

Device Class : 1

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Bone Marrow "J" Needle Double Diamond Tip - 00813079020240 Catalog Number : JD-1104

Device Description : 11ga (3.0mm) x 4in. (10cm)

Device Class :

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Bone Marrow "J" Needle Double Diamond Tip - 00813079020257 Catalog Number : JD-1106

Device Description : 11ga (3.0mm) x 6in. (15cm)

Device Class : 1

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

Bone Marrow "J" Needle with Double Diamond Tip - 00813079020264 Catalog Number : JD-1104-NS

Device Description : 11ga (3.0mm) x 4in. (10.2cm)

Device Class : 1

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 25

Guidewire Introducer Needle Winged Base Plate - 00813079020271 Catalog Number : BGWI-1802

Device Description : 18ga (1.3mm) x 7cm

Device Class : 1

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Guidewire Introducer Needle Winged Base Plate - 00813079020295 Catalog Number : BGWI-1902

Device Description : 19ga (1.1mm) x 7cm

Device Class : 1

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Guidewire Introducer Needle - 00813079020301 Catalog Number : GWI-1802

Device Description : 18ga (1.3mm) x 7cm

Device Class : 1

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Guidewire Introducer Needle Square Hub Access Needle - 00813079020325 Catalog Number : GWI-1820WW

Device Description : 18ga (1.3mm) x 7cm

Device Class :

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

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