DIVERSATEK HEALTHCARE, INC.

Address:9150 Commerce Center Cir Ste 500,Highlands Ranch,CO,80129,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

Bougie, Esophageal, And Gastrointestinal, Gastro-Urology (FAT) (10)

Premarket Exempt

No Yes

Clear

M-Flex® - 00816734020401 Catalog Number : 1207-54

Device Description : Blue Silicone Tungsten Hurst Esophageal Dilator, 54 French

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : FAT

Prescription Use : Yes

Device Count : 1

M-Flex® - 00816734020418 Catalog Number : 1207-56

Device Description : Blue Silicone Tungsten Hurst Esophageal Dilator, 56 French

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : FAT

Prescription Use : Yes

Device Count : 1

M-Flex® - 00816734020425 Catalog Number : 1207-58

Device Description : Blue Silicone Tungsten Hurst Esophageal Dilator, 58 French

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : FAT

Prescription Use : Yes

Device Count : 1

M-Flex® - 00816734020432 Catalog Number : 1207-60

Device Description : Blue Silicone Tungsten Hurst Esophageal Dilator, 60 French

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : FAT

Prescription Use : Yes

Device Count : 1

M-Flex® - 00816734020449 Catalog Number : 1207-00

Device Description : Blue Silicone Tungsten Hurst Bougie Set

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : FAT

Prescription Use : Yes

Device Count : 1

M-Flex® - 00816734020456 Catalog Number : 1207-10

Device Description : Blue Silicone Tungsten Hurst Bougie Mini-Set

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : FAT

Prescription Use : Yes

Device Count : 1

WeightRight® - 00816734020463 Catalog Number : 1208-16

Device Description : Tungsten-Filled Maloney Esophageal Dilator, 16 French

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : FAT

Prescription Use : Yes

Device Count : 1

WeightRight® - 00816734020470 Catalog Number : 1208-18

Device Description : Tungsten-Filled Maloney Esophageal Dilator, 18 French

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : FAT

Prescription Use : Yes

Device Count : 1

WeightRight® - 00816734020487 Catalog Number : 1208-20

Device Description : Tungsten-Filled Maloney Esophageal Dilator, 20 French

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : FAT

Prescription Use : Yes

Device Count : 1

WeightRight® - 00816734020494 Catalog Number : 1208-22

Device Description : Tungsten-Filled Maloney Esophageal Dilator, 22 French

Device Class : 2

Duns Number: 030650113

Premarket Exempt : No

Product Code : FAT

Prescription Use : Yes

Device Count : 1

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