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

Pin, Fixation, Smooth (HTY) (6) Cannula, Manipulator/Injector, Uterine (LKF) (3)

Premarket Exempt

Clear

HNM MEDICAL - 00842962106242 Catalog Number : HKW-12-120040

Device Description : ø4.0mm STEINMANN PIN, 12", SINGLE TROCAR (ROUND END), SMOOTH

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HNM MEDICAL - 00842962106259 Catalog Number : HKW-12-120045

Device Description : ø4.5mm STEINMANN PIN, 12", SINGLE TROCAR (ROUND END), SMOOTH

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HNM MEDICAL - 00842962106266 Catalog Number : HKW-12-023410

Device Description : ø1.0mm K-WIRE, 2 3/4", SINGLE TOCAR (ROUND END), SMOOTH

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HNM MEDICAL - 00842962106273 Catalog Number : HKW-12-060010

Device Description : ø1.0mm K-WIRE, 6", SINGLE TOCAR (ROUND END), SMOOTH

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HNM MEDICAL - 00842962106280 Catalog Number : HKW-12-023414

Device Description : ø1.4mm K-WIRE, 2 3/4", SINGLE TOCAR (ROUND END), SMOOTH

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HNM MEDICAL - 00842962106297 Catalog Number : HKW-12-060024

Device Description : ø2.4mm STEINMANN PIN, 6", SINGLE TROCAR (ROUND END), SMOOTH

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : HTY

Prescription Use : Yes

Device Count : 1

HNM Women Care - 10842962105242 Catalog Number : HBI-UIC5FA

Device Description : BELLOTA SONOHYSTEROGRAPHY CATHETER W/CERVICAL CONE, 5 Fr, 350mm, NON-BALLOON, ST BELLOTA SONOHYSTEROGRAPHY CATHETER W/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 - 10842962105266 Catalog Number : HBI-BA051F

Device Description : HSG CATHETER SET W/BALLOON, 5 Fr, SUREFLEX, 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 - 10842962105273 Catalog Number : HBI-BA071F

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

Device Class : 2

Duns Number: 806754185

Premarket Exempt : No

Product Code : LKF

Prescription Use : Yes

Device Count : 10

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