ENDURE INDUSTRIES

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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

Airway, Oropharyngeal, Anesthesiology (CAE) (8) Airway, Nasopharyngeal (BTQ) (2)

Premarket Exempt

No Yes

Clear

Endure - B531NPS3220 Catalog Number : NPS322

Device Description : Nasopharyngeal Airway, Size = 32 Fr, Internal Diameter 7 inches

Device Class :

Duns Number: 066087031

Premarket Exempt : Yes

Product Code : BTQ

Prescription Use : Yes

Device Count : 1

Endure - B531NPS3420 Catalog Number : B531NPS342

Device Description : Nasopharyngeal Airway, Size = 34 Fr, Internal Diameter 7.5 inches

Device Class :

Duns Number: 066087031

Premarket Exempt : Yes

Product Code : BTQ

Prescription Use : Yes

Device Count : 1

Endure - B531OA1020 Catalog Number : OA102

Device Description : Oropharyngeal Airway, Size 100 mm, Non-Sterile

Device Class : 1

Duns Number: 066087031

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Endure - B531OA1120 Catalog Number : OA112

Device Description : Oropharyngeal Airway, Size 110 mm, Non-Sterile

Device Class : 1

Duns Number: 066087031

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Endure - B531OA1220 Catalog Number : OA122

Device Description : Oropharyngeal Airway, Size 120 mm, Non-Sterile

Device Class : 1

Duns Number: 066087031

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Endure - B531OA420 Catalog Number : OA42

Device Description : Oropharyngeal Airway, Size 40, Non-Sterile

Device Class : 1

Duns Number: 066087031

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Endure - B531OA520 Catalog Number : OA52

Device Description : Oropharyngeal Airway, Size 50, Non-Sterile

Device Class : 1

Duns Number: 066087031

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Endure - B531OA620 Catalog Number : OA62

Device Description : Oropharyngeal Airway, Size 60, Non-Sterile

Device Class : 1

Duns Number: 066087031

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Endure - B531OA720 Catalog Number : OA72

Device Description : Oropharyngeal Airway, Size 70, Non-Sterile

Device Class : 1

Duns Number: 066087031

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

Endure - B531OA820 Catalog Number : OA82

Device Description : Oropharyngeal Airway, Size 80 mm, Non-Sterile

Device Class : 1

Duns Number: 066087031

Premarket Exempt : Yes

Product Code : CAE

Prescription Use : Yes

Device Count : 1

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