STRYKER MEDTECH K.K.

STRYKER MEDTECH K.K.

Address:1131-1 HIGASHI NAGANUMA,INAGI Tokyo,JP

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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

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE (MDM) (7) Instrument, ultrasonic surgical (LFL) (2) SPLINT, INTRANASAL SEPTAL (LYA) (1)

Premarket Exempt

No Yes

Clear

NA - 07613327289886 Catalog Number : 5450800040

Device Description : Lock Wrench

Device Class : 1

Duns Number: 690682147

Premarket Exempt : No

Product Code : MDM

Prescription Use : Yes

Device Count : 1

Hyper LT - 07613327289893 Catalog Number : 5450814000

Device Description : Angled Hard Tissue Curette Handpiece without Tip, 25 kHz

Device Class : U

Duns Number: 690682147

Premarket Exempt : No

Product Code : LFL

Prescription Use : Yes

Device Count : 1

NA - 07613327290202 Catalog Number : 5450825000

Device Description : Universal Handpiece Kit

Device Class : 1

Duns Number: 690682147

Premarket Exempt : No

Product Code : LYA

Prescription Use : Yes

Device Count : 1

NA - 07613327291483 Catalog Number : 5450-800-024

Device Description : Torque Wrench, 1.96 Nm - 7 mm

Device Class : 1

Duns Number: 690682147

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

NA - 07613327291490 Catalog Number : 5450800030

Device Description : Wrench, 10 mm

Device Class : 1

Duns Number: 690682147

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

NA - 07613327291520 Catalog Number : 5450-800-038

Device Description : Step Torque Wrench, Offset, 7 mm

Device Class : 1

Duns Number: 690682147

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

NA - 07613327291537 Catalog Number : 5450-800-276

Device Description : Cleaning Wire

Device Class : 1

Duns Number: 690682147

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

NA - 07613327291568 Catalog Number : 5450800029

Device Description : Wrench, 7 mm

Device Class : 1

Duns Number: 690682147

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

NA - 07613327291575 Catalog Number : 5450800025

Device Description : Torque Wrench, 4.9 Nm - 10 mm

Device Class : 1

Duns Number: 690682147

Premarket Exempt : Yes

Product Code : MDM

Prescription Use : Yes

Device Count : 1

NA - 07613327291803 Catalog Number : 5450804000

Device Description : Small Long Angled Handpiece without Tip, 34 kHz

Device Class : U

Duns Number: 690682147

Premarket Exempt : No

Product Code : LFL

Prescription Use : Yes

Device Count : 1

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