INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Address:Unit No.12,Pune Maharashtra,IN

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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

Tap, Bone (HWX) (7) Screwdriver (HXX) (3)

Premarket Exempt

No Yes

Clear

ACURA Stabilization System - Final Tightening Driver - B922F00403210 Catalog Number : F004.0321

Device Description : Final Tightening Driver

Device Class : 1

Duns Number: 860396609

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

ACURA Stabilization System - Final Tightening Driver, Long - B922F00403220 Catalog Number : F004.0322

Device Description : Final Tightening Driver, Long

Device Class : 1

Duns Number: 860396609

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

4.5 mm Tap - B922F00403450 Catalog Number : F004.0345

Device Description : 4.5 mm Tap

Device Class : 1

Duns Number: 860396609

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Tapered Tap - 5.5 mm - B922F00403550 Catalog Number : F004.0355

Device Description : Tapered Tap - 5.5 mm

Device Class : 1

Duns Number: 860396609

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Tapered Tap - 6.5 mm - B922F00403650 Catalog Number : F004.0365

Device Description : Tapered Tap - 6.5 mm

Device Class : 1

Duns Number: 860396609

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Tapered Tap - 7.5 mm - B922F00403750 Catalog Number : F004.0375

Device Description : Tapered Tap - 7.5 mm

Device Class : 1

Duns Number: 860396609

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Tapered Tap - 8.5 mm - B922F00403850 Catalog Number : F004.0385

Device Description : Tapered Tap - 8.5 mm

Device Class : 1

Duns Number: 860396609

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Cannulated Tap - 4.5 mm - B922F00404450 Catalog Number : F004.0445

Device Description : Cannulated Tap - 4.5 mm

Device Class : 1

Duns Number: 860396609

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

Cannulated Tap - 5.5 mm - B922F00404550 Catalog Number : F004.0455

Device Description : Cannulated Tap - 5.5 mm

Device Class : 1

Duns Number: 860396609

Premarket Exempt : Yes

Product Code : HWX

Prescription Use : Yes

Device Count : 1

ACURA Stabilization System - T-20 Connector Driver - B922F00480010 Catalog Number : F004.8001

Device Description : T-20 Connector Driver

Device Class : 1

Duns Number: 860396609

Premarket Exempt : Yes

Product Code : HXX

Prescription Use : Yes

Device Count : 1

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