Mastel Precision Surgical Instruments, Inc.

Address:2843 SAMCO RD., SUITE A,RAPID CITY,SD,57702,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

Knife, Ophthalmic (HNN) (10)

Premarket Exempt

Yes

Clear

Mastel Precision Surgical Instruments, Inc. - 00642356100210 Catalog Number : 10.302.2013

Device Description : President Meister (UltraThin Lance T.), Angled Mount

Device Class : 1

Duns Number: 789897865

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 1

Mastel Precision Surgical Instruments, Inc. - 00642356100227 Catalog Number : 10.302.2014

Device Description : President Price Fine Triamond .5 Tip, Angled Mount

Device Class : 1

Duns Number: 789897865

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 1

Mastel Precision Surgical Instruments, Inc. - 00642356100234 Catalog Number : 10.302.2015

Device Description : President SafetyPort 55°, Angled Mount

Device Class : 1

Duns Number: 789897865

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 1

Mastel Precision Surgical Instruments, Inc. - 00642356100241 Catalog Number : 10.302.2016

Device Description : President Stealth Fine Triamond .3 Tip, Angled Mount

Device Class : 1

Duns Number: 789897865

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 1

Mastel Precision Surgical Instruments, Inc. - 00642356100258 Catalog Number : 10.302.2018

Device Description : President Stealth Enh. Lance 60° Sharp Tip, Angled Mount

Device Class : 1

Duns Number: 789897865

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 1

Mastel Precision Surgical Instruments, Inc. - 00642356100265 Catalog Number : 10.302.2019

Device Description : President Stealth Enh. Lance 60° Trunc. Tip, Angled Mount

Device Class : 1

Duns Number: 789897865

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 1

Mastel Precision Surgical Instruments, Inc. - 00642356100272 Catalog Number : 10.302.2020

Device Description : President ParaTriamond .7/1.2 Trunc. Tip, Angled Mount

Device Class : 1

Duns Number: 789897865

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 1

Mastel Precision Surgical Instruments, Inc. - 00642356100289 Catalog Number : 10.302.2021

Device Description : President Fine ParaTrap .7/1.2 Sharp Tip, Angled Mount

Device Class : 1

Duns Number: 789897865

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 1

Mastel Precision Surgical Instruments, Inc. - 00642356100296 Catalog Number : 10.302.2022

Device Description : President Fine ParaTrap .7/1.2 Trunc. Tip, Angled Mount

Device Class : 1

Duns Number: 789897865

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 1

Mastel Precision Surgical Instruments, Inc. - 00642356100302 Catalog Number : 10.303.2023

Device Description : President Fine ParaTrap 1.1/1.4 Sharp Tip, Angled Mount

Device Class : 1

Duns Number: 789897865

Premarket Exempt : Yes

Product Code : HNN

Prescription Use : No

Device Count : 1

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