GAUTHIER BIOMEDICAL, INC.

Address:2221 Washington Street,Grafton,WI,53024,US

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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

Orthopedic Manual Surgical Instrument (LXH) (9) Wrench (HXC) (1)

Premarket Exempt

No Yes

Clear

Gauthier Biomedical - 00858325005329 Catalog Number : G123952

Device Description : Ratcheting T-Handle, Hybrid Hudson Connection

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005336 Catalog Number : G916302

Device Description : Torque Limiter, 3 Nm, 7/32 inch (5,56 mm) Hex

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005343 Catalog Number : G817562

Device Description : 4-SIDED INLINE RATCHETING HANDLE 1/4 inch (6,35 mm) SQUARE SECURE SHAFT CONNECT 4-SIDED INLINE RATCHETING HANDLE 1/4 inch (6,35 mm) SQUARE SECURE SHAFT CONNECT (Distributor Part # 110003457)

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005350 Catalog Number : G851100

Device Description : Ultra Mini Torque T- Handle with Tri-Flat Quick Connect

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005367 Catalog Number : G178104

Device Description : PALM HANDLE TORQUE LIMITER 1/4 inch (6,35mm) SQUARE SECURE SHAFT, 4Nm

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005374 Catalog Number : G900037

Device Description : G10 LARGE INLINE RATCHETING HANDLE, SMALL HUDSON PULL COLLAR

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005381 Catalog Number :

Device Description : INLINE RATCHETING TORQUE LIMITER, 1/4 inch (6,35 mm) SQUARE CONNECT

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005398 Catalog Number : 71094104

Device Description : INLINE TORQUE ADAPTER, HALL JACOBS SHAFT, 10mm HEX SOCKET, 35 in lbs (3,95 Nm) ( INLINE TORQUE ADAPTER, HALL JACOBS SHAFT, 10mm HEX SOCKET, 35 in lbs (3,95 Nm) (Smith & Nephew # 71094104 - MAVERICK (TM) Afterburner 10 mm )

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005404 Catalog Number :

Device Description : BALANCED T-HANDLE TORQUE LIMITER, 1/4 inch (6,35 mm) SQUARE CONNECT

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 10858325005180 Catalog Number : G440350

Device Description : Pack of Two G440350 Electronic Torque Indicator pencil grip, Fixed AO pull connect

Device Class :

Duns Number: 015227072

Premarket Exempt : No

Product Code : HXC

Prescription Use : Yes

Device Count : 2

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