Tradex International, Inc.

Tradex International, Inc.

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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

Latex patient examination glove (LYY) (6) Polymer patient examination glove (LZA) (4)

Premarket Exempt

No

Clear

AMBITEX - 00699320000076 Catalog Number : NLG200G

Device Description : AMBITEX NITRILE EXAM GREEN PF LG 10/100

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

AMBITEX - 00699320000151 Catalog Number : NMD200G

Device Description : AMBITEX NITRILE EXAM GREEN PF MD 10/100

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

AMBITEX - 00699320000199 Catalog Number : NSM200G

Device Description : AMBITEX NITRILE EXAM GREEN PF SM 10/100

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

AMBITEX - 00699320000236 Catalog Number : NXL200G

Device Description : AMBITEX NITRILE EXAM GREEN PF XL 10/100

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 100

AMBITEX - 00699320102145 Catalog Number : LLG800

Device Description : AMBITEX LATEX EXAM GLV PF LG

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

AMBITEX - 00699320102220 Catalog Number : LSM620

Device Description : AMBITEX LATEX HIGH RISK EXAM SM

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 50

AMBITEX - 00699320102237 Catalog Number : LMD620

Device Description : AMBITEX LATEX HIGH RISK EXAM PF MD

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 50

AMBITEX - 00699320102244 Catalog Number : LLG620

Device Description : AMBITEX LATEX HIGH RISK EXAM PF LG

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 50

AMBITEX - 00699320102251 Catalog Number : LXL620

Device Description : AMBITEX LATEX HIGH RISK EXAM XL

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 50

AMBITEX - 00699320107911 Catalog Number : LXS240

Device Description : AMBITEX LATEX EXAM PF XS

Device Class :

Duns Number: 196027981

Premarket Exempt : No

Product Code : LYY

Prescription Use : No

Device Count : 100

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