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

Medical gloves with chemotherapy labeling claims - test for use with chemotherapy drugs (OPJ) (5) Vinyl patient examination glove (LYZ) (5)

Premarket Exempt

No Yes

Clear

OmniTrustTM - 00810572001165 Catalog Number : 212-20

Device Description : Nitrile Examination Glove Powder Free X-Small

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : OPJ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001172 Catalog Number : 212-21

Device Description : Nitrile Examination Glove Powder Free Small

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : OPJ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001189 Catalog Number : 212-22

Device Description : Nitrile Examination Glove Powder Free Medium

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : OPJ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001196 Catalog Number : 212-23

Device Description : Nitrile Examination Glove Powder Free Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : OPJ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001202 Catalog Number : 212-24

Device Description : Nitrile Examination Glove Powder Free X-Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : OPJ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001271 Catalog Number : 312-11

Device Description : Vinyl Examination Glove Powder Free Small

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001288 Catalog Number : 312-12

Device Description : Vinyl Examination Glove Powder Free Medium

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001295 Catalog Number : 312-13

Device Description : Vinyl Examination Glove Powder Free Large

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

OmniTrustTM - 00810572001301 Catalog Number : 312-14

Device Description : 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 - 00810572001370 Catalog Number : 412-01

Device Description : Synethic Vinyl Examination Glove Powder Free Small

Device Class :

Duns Number: 079434709

Premarket Exempt : No

Product Code : LYZ

Prescription Use : No

Device Count : 100

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