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 - 00858325005220 Catalog Number : G412162

Device Description : Balanced T-Torque, 1 / 4 inch (6,35mm) Square, 8Nm

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005237 Catalog Number : G415163

Device Description : Offset 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

Gauthier Biomedical - 00858325005244 Catalog Number : G914559

Device Description : G10 T-Handle Ratchet, 1 / 4 Inch (6,35 mm) Square, Reverse Impaction

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005251 Catalog Number : GC100184

Device Description : Shaft, 1 / 4 inch (6,35mm) Square to 5mm Hex

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005268 Catalog Number : GC100185

Device Description : Shaft, 1 / 4 inch (6,35mm) Square to 4mm Hex

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005275 Catalog Number : G912111

Device Description : G10 Palm Handle Ratchet, 1 / 4 Inch (6,35 mm) Square, Reverse Impaction

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005282 Catalog Number : G900021

Device Description : G10 Inline Handle Ratchet, 1 / 4 Inch (6,35 mm) Square, Reverse Impaction

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005299 Catalog Number : G901022

Device Description : G10 MINI INLINE RATCHETING HANDLE, AO PULL COLLAR

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Gauthier Biomedical - 00858325005305 Catalog Number : G851204

Device Description : Fixed Ultra Mini T-Handle 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 - 00858325005312 Catalog Number : G207165

Device Description : Inline Torque Adapter, Male Hall - Jacobs, 0.358 inch Hex Socket

Device Class : 1

Duns Number: 015227072

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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