HNM STAINLESS, LLC.

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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

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (7) Cannula, Manipulator/Injector, Uterine (LKF) (3)

Premarket Exempt

Clear

HNM Women Care - 00812171023906 Catalog Number : HBI-UIC5F

Device Description : BELLOTA SONOHYSTEROGRAPHY CATHETER W/O CERVICAL CONE, 5 Fr, 350mm, NON-BALLOON, BELLOTA SONOHYSTEROGRAPHY CATHETER W/O CERVICAL CONE, 5 Fr, 350mm, NON-BALLOON, STERILE, BOX OF 25

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 25

HNM Women Care - 00812171023920 Catalog Number : HBI-BA05F

Device Description : HSG CATHETER SET W/BALLOON, 5Fr, STERILE, BOX OF 10

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 10

HNM Women Care - 00812171023937 Catalog Number : HBI-BA07F

Device Description : HSG CATHETER SET W/BALLOON, 7Fr, STERILE, BOX OF 10

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 10

HNM MEDICAL - 00812171024668 Catalog Number : HNM-103.02

Device Description : YELLOW SAFETY LID

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HNM MEDICAL - 00812171024675 Catalog Number : HNM-103.04

Device Description : BLUE SAFETY LID FOR HNM-110.10W STERILIZATION CONTAINER, 22 7/8"X11"X4"

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HNM MEDICAL - 00812171024682 Catalog Number : HNM-103.01

Device Description : SAFETY LID, 23"X11"

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HNM MEDICAL - 00812171024699 Catalog Number : HNM-105.10W

Device Description : STERILIZATION CONTAINER, BOTTOM NON PERFORATED, 22 7/8"X11"X4", NO LID, BASIC

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HNM MEDICAL - 00812171024705 Catalog Number : HNM-105.13W

Device Description : STERILIZATION CONTAINER, BOTTOM NON PERF, 22 7/8"X11"X5 3/8", NO LID, BASIC

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HNM MEDICAL - 00812171024712 Catalog Number : HNM-105.15W

Device Description : STERILIZATION CONTAINER, BOTTOM NON PERFORATED, 22 7/8"X11"X6", NO LID, BASIC

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

HNM MEDICAL - 00812171024729 Catalog Number : HNM-105.20W

Device Description : STERILIZATION CONTAINER, BOTTOM NON PERFORATED, 22 7/8"X11"X8", NO LID, BASIC

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 1

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