SWIFT HEALTH SYSTEMS INC.

Address:5 Goodyear,Irvine,CA,92618,US

Want to know more about this Organization? Request more information now!

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

Orthodontic Software (PNN) (7) Instruments, Dental Hand (DZN) (2)

Premarket Exempt

No Yes

Clear

Inbrace Teeth Straightening System - 00850018135009 Catalog Number : 8101

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

Inbrace Teeth Straightening System - 00850018135016 Catalog Number : 8111

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

InBrace Teeth Straightening System (Gen 2.0) - 00850018135030 Catalog Number : 85002

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

InBrace Teeth Straightening System (Gen 2.0) - 00850018135047 Catalog Number : 85000

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

InBrace Teeth Straightening System (Gen 2.0) - 00850018135054 Catalog Number : 85003

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

Inbrace Teeth Straightening System - 00850018135122 Catalog Number : 8131

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

Inbrace Teeth Straightening System - 00850018135139 Catalog Number : 8121

Device Class : 2

Duns Number: 884398210

Premarket Exempt : No

Product Code : PNN

Prescription Use : Yes

Device Count : 1

Smartwire InGager - 00850018135399 Catalog Number : 85001

Device Description : An orthodontic reusable instrument intended for use with the InBrace Teeth Strai

Device Class : 1

Duns Number: 884398210

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : Yes

Device Count : 1

InBrace Starter Kit - 10850018135396 Catalog Number : 83000

Device Description : This device is a kit containing 3 Smartwire InGager instruments and spare bracke

Device Class : 1

Duns Number: 884398210

Premarket Exempt : Yes

Product Code : DZN

Prescription Use : Yes

Device Count : 1

Previous 1 Next