MEDI-TECH INTERNATIONAL CORPORATION

Address:26 Court St Ste 1301,BROOKLYN,NY,11242,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

Dressing, Wound, Hydrogel Without Drug And/Or Biologic (NAE) (9) Garment, Protective, For Incontinence (EYQ) (1)

Premarket Exempt

No Yes

Clear

MediBrief Longer Torso - 00027479251009 Catalog Number : MBLT25100

Device Description : MediBrief Longer Torso Seamless Knit Pant - Size 4XL (Bariatric) Bulk 100/CS

Device Class : 1

Duns Number: 063865158

Premarket Exempt : Yes

Product Code : EYQ

Prescription Use : No

Device Count : 1

Spand-Gel - 00027479251016 Catalog Number : SPHFM1

Device Description : Spand-Gel Hydrogel Dressing Sheet - Full Face Mask - Sterile

Device Class : 1

Duns Number: 063865158

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Spand-Gel - 00027479251023 Catalog Number : SPHFM2

Device Description : Spand-Gel Hydrogel Dressing Sheet - Half Face Mask - Sterile

Device Class : 1

Duns Number: 063865158

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Spand-Gel - 00027479251030 Catalog Number : SPHBW1

Device Description : Spand-Gel Hydrogel Dressing Sheet - Breast Wrap - Sterile

Device Class : 1

Duns Number: 063865158

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Spand-Gel - 00027479251047 Catalog Number : SPHNW1

Device Description : Spand-Gel Hydrogel Dressing Sheet - Neck Wrap - Sterile

Device Class : 1

Duns Number: 063865158

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Spand-Gel - 00027479251054 Catalog Number : SPHSA2

Device Description : Spand-Gel Hydrogel Dressing Sheet - Size 2 IN x 2 IN - Sterile

Device Class : 1

Duns Number: 063865158

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Spand-Gel - 00027479251061 Catalog Number : SPHSA3

Device Description : Spand-Gel Hydrogel Dressing Sheet - Size 3 IN x 8 IN - Sterile

Device Class : 1

Duns Number: 063865158

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Spand-Gel - 00027479251078 Catalog Number : SPHSA4

Device Description : Spand-Gel Hydrogel Dressing Sheet - Size 4 IN x 4 IN- Sterile

Device Class : 1

Duns Number: 063865158

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Spand-Gel - 00027479251085 Catalog Number : SPHSA4.5

Device Description : Spand-Gel Hydrogel Dressing Sheet - Size 4 IN x 5 IN - Sterile

Device Class : 1

Duns Number: 063865158

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

Spand-Gel - 00027479251092 Catalog Number : SPHSA5

Device Description : Spand-Gel Hydrogel Dressing Sheet - Size 5 IN x 9 IN - Sterile

Device Class : 1

Duns Number: 063865158

Premarket Exempt : Yes

Product Code : NAE

Prescription Use : No

Device Count : 1

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