SUN MEDICAL INC

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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

Apparatus, Exhaust, Surgical (FYD) (3) Extractor, Vacuum, Fetal (HDB) (2)

Premarket Exempt

No Yes

Clear

Sun Medical Inc - B226845000 Catalog Number : 84500

Device Description : Aspirator Tubing with Swivel Handle

Device Class : 2

Duns Number: 095223103

Premarket Exempt : Yes

Product Code : HDB

Prescription Use : No

Device Count : 1

Sun Medical Inc - B226845002 Catalog Number : 84500

Device Description : Aspirator Tubing with Swivel Handle

Device Class :

Duns Number: 095223103

Premarket Exempt : Yes

Product Code : HDB

Prescription Use : No

Device Count : 25

Sun Medical Inc - B22687300000 Catalog Number : 8730000

Device Description : Smoke Evacuator Circuit

Device Class : 2

Duns Number: 095223103

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

Sun Medical Inc - B22687300001 Catalog Number : 8730000

Device Description : Smoke Evacuator Circiut

Device Class :

Duns Number: 095223103

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 12

Sun Medical Inc - B22691200000 Catalog Number : 9120000

Device Description : Smoke/Fluid evacuator system

Device Class : 2

Duns Number: 095223103

Premarket Exempt : No

Product Code : FYD

Prescription Use : No

Device Count : 1

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