MYELOTEC, 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

Arthroscope (HRX) (5)

Premarket Exempt

Clear

Video Guided Catheter - M79320105 Catalog Number : 2010

Device Description : 3.0 Video Guided Catheter

Device Class :

Duns Number: 006731844

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 5

NaviCath - M79320175 Catalog Number : 2017

Device Description : NaviCath Steerable Catheter Kit

Device Class :

Duns Number: 006731844

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 5

Video Guided Catheter - M79320335 Catalog Number : 2033

Device Description : Video Guided Catheter

Device Class :

Duns Number: 006731844

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 5

Epiduroscopy Introducer Set - M79340075 Catalog Number : 4007

Device Class :

Duns Number: 006731844

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 5

Epiduroscopy Introducer Set - M79340085 Catalog Number : 4008

Device Description : Epiduroscopy Introducer Set

Device Class :

Duns Number: 006731844

Premarket Exempt : No

Product Code : HRX

Prescription Use : Yes

Device Count : 5

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