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 - 00858325005008 Catalog Number : G900000

Device Description : Multi-Color Inline Ratcheting Handle

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005015 Catalog Number : G900100

Device Description : Multi-Color Ratcheting T-Handle

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005022 Catalog Number : G109800

Device Description : Torque Limiter with Impact cap, Mini T-Handle

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005039 Catalog Number : G850000

Device Description : Tri-flat Quick Connect Fixed Inline Handle

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005046 Catalog Number : G911000

Device Description : AO Quick Connect Two Color Fixed Inline Handle

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005053 Catalog Number : GC101210

Device Description : Articulated Shaft Small AO T27 Torx tip

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005060 Catalog Number : G107212

Device Description : This hand - held, orthopedic, manual, surgical instrument handle is designed to This hand - held, orthopedic, manual, surgical instrument handle is designed to connect to shaft type instruments, such as awls, taps, screw drivers and similar instruments used by a surgeon to prepare fasteners or constructs for installation, driving or adjusting fasteners or to perform manipulations during surgery. This is a reusable device.

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005077 Catalog Number : G851200

Device Description : 4,75mm Square Fixed Ultra Mini T-Handle

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005084 Catalog Number : G178101

Device Description : 1/4 inch (6,35mm) Square Secure Shaft Connector Extended Palm Torque Limiter Handle

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005091 Catalog Number : G170059

Device Description : 1/4 inch (6,35mm) Square Connector Palm Style Ratcheting Handle

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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