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, TUMOR LOCALIZATION (MIJ) (4) System, x-ray, mammographic (IZH) (3) INSTRUMENTS, SURGICAL, CARDIOVASCULAR (DWS) (2) NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE (GAA) (1)

Premarket Exempt

No Yes

Clear

Guidewire Introducer Needle - 00813079020332 Catalog Number : GWI-1902

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

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 - 00813079020349 Catalog Number : GWI-1902WW

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

Device Class :

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : DWS

Prescription Use : Yes

Device Count : 1

Breast Needle Locator - 00813079020363 Catalog Number : BNL-2003

Device Description : 20ga (0.9mm) x 3cm

Device Class :

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : MIJ

Prescription Use : Yes

Device Count : 1

Breast Needle Locator - 00813079020370 Catalog Number : BNL-2005

Device Description : 20ga (0.9mm) x 5cm

Device Class : 1

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : MIJ

Prescription Use : Yes

Device Count : 1

Breast Needle Locator - 00813079020387 Catalog Number : BNL-2007

Device Description : 20ga (0.9mm) x 7cm

Device Class :

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : MIJ

Prescription Use : Yes

Device Count : 1

Breast Needle Locator - 00813079020394 Catalog Number : BNL-2010

Device Description : 20ga (0.9mm) x 10cm

Device Class :

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : MIJ

Prescription Use : Yes

Device Count : 1

Closed Needle Guide - 00813079020400 Catalog Number : LNGC-14

Device Description : 14ga (2.1mm)

Device Class :

Duns Number: 788472314

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 1

Closed Needle Guide - 00813079020417 Catalog Number : LNGC-2022

Device Description : 20/22ga (0.9/0.7mm)

Device Class :

Duns Number: 788472314

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 2

Open Needle Guide - 00813079020424 Catalog Number : LNGO-2022

Device Description : 20/22ga (0.9/0.7mm)

Device Class :

Duns Number: 788472314

Premarket Exempt : No

Product Code : IZH

Prescription Use : Yes

Device Count : 2

Franseen Needle Marked - 00813079020431 Catalog Number : FNM-1806

Device Description : 18ga (1.3mm) x 15cm

Device Class : 1

Duns Number: 788472314

Premarket Exempt : Yes

Product Code : GAA

Prescription Use : Yes

Device Count : 1

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