OMNI INTERNATIONAL CORP.

Address:35 Constitution Dr Ste 1D,BEDFORD,NH,03110,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

Polymer patient examination glove (LZA) (7) Vinyl patient examination glove (LYZ) (3)

Premarket Exempt

No Yes

Clear

OmniTrustTM - 00810572001387 Catalog Number : 412-02

Device Description : Synethic Vinyl Examination Glove Powder Free Medium

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001394 Catalog Number : 412-03

Device Description : Synethic Vinyl Examination Glove Powder Free Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001400 Catalog Number : 412-04

Device Description : Synethic Vinyl Examination Glove Powder Free X-Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001523 Catalog Number : 214-21

Device Description : Nitrile Examination Glove Powder Free Small

Device Class : 1

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572001530 Catalog Number : 214-22

Device Description : Nitrile Examination Glove Powder Free Medium

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572001547 Catalog Number : 214-23

Device Description : Nitrile Examination Glove Powder Free Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572001554 Catalog Number : 214-24

Device Description : Nitrile Examination Glove Powder Free X-Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572001592 Catalog Number : 203-21

Device Description : Nitrile Examination Glove Powder Free Small

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572001608 Catalog Number : 203-22

Device Description : Nitrile Examination Glove Powder Free Medium

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

OmniTrustTM - 00810572001615 Catalog Number : 203-23

Device Description : Nitrile Examination Glove Powder Free Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LZA

Prescription Use : No

Device Count : 200

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