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) (10)

Premarket Exempt

No Yes

Clear

Gauthier Biomedical - 00858325005107 Catalog Number : G852402

Device Description : Ultra Mini Ratcheting Inline 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 - 00858325005114 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 - 00858325005121 Catalog Number : G601050

Device Description : Cervical Compressor for 3,2 - 3,5 mm rods

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005138 Catalog Number : G602050

Device Description : Cervical Distractor for 3,2 - 3,5 mm rods

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005145 Catalog Number : G700251

Device Description : Ratcheting Torque Limiting Allen Wrench

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005169 Catalog Number : G140553

Device Description : Low Torque T-Handle (Distributor Part Number 254600410)

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005176 Catalog Number : G119852

Device Description : Fiber Tape (R) Cerclage Tensioner (Gauthier Part # G119852)

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005190 Catalog Number : G114040

Device Description : OSTEO CONTROL ™ ACCELERATED HANDLE

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005206 Catalog Number : G207163

Device Description : Inline Torque Adapter, Male Hudson/Zimmer with 1 / 4 inch (6,35 mm) Square Quick Connect

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005213 Catalog Number : G412161

Device Description : Balanced T-Torque, 1 / 4 inch (6,35mm) Square, 12Nm

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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