AUSTIN MEDICAL

Address:190-A Industrial Park Drive,Waynesville,NC,28786,US

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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

Drape, Surgical (KKX) (6)

Premarket Exempt

Clear

Austin - 00850017635418 Catalog Number : A-AU-10-122S

Device Description : Mother’s Viewing Drape with Bleed ID Window

Device Class : 2

Duns Number: 010058700

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Austin Medical - 00866001000308 Catalog Number : AU-0984SC

Device Description : Mother’s Viewing Drape - C-Section-sterile

Device Class : 2

Duns Number: 010058700

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Clear Horizon - 00866001000322 Catalog Number : AU-1008S

Device Description : "24"" x 24"" SMS Eye Drape w/ 1 fluidcontrol pouch & 4"" x 5"" w/ Incise"

Device Class : 2

Duns Number: 010058700

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Austin - 00866001000339 Catalog Number : Au-10-143S

Device Description : Total Capture Hysteroscopy Drape

Device Class : 2

Duns Number: 010058700

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

Austin Medical, Inc. - 00866001000353 Catalog Number : HemviewCSD01

Device Description : Hemorrhage View C-section Drape

Device Class : 2

Duns Number: 010058700

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

Austin Medical, Inc. - 00866001000391 Catalog Number : A800-0310

Device Description : Protego Pro Kit

Device Class : 2

Duns Number: 010058700

Premarket Exempt : No

Product Code : KKX

Prescription Use : No

Device Count : 1

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