FDA.reportPublic FDA data

Gauthier Biomedical

Primary DI
00858325005398
Brand
Gauthier Biomedical
Company
GAUTHIER BIOMEDICAL, INC.
Model
G207166
Catalog number
71094104
Device description
INLINE TORQUE ADAPTER, HALL JACOBS SHAFT, 10mm HEX SOCKET, 35 in lbs (3,95 Nm) (Smith & Nephew # 71094104 - MAVERICK (TM) Afterburner 10 mm )
Published
2021-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858325005398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858325005398008583250053988583250053980858325005398

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1-262-546-0010xxxx@xxxx.com

Regulatory Flags#

DUNS number
015227072
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858325005572Gauthier Biomedical5161-00-5021 (GC150085-20)51610050212023-11-27
00858325005589Gauthier Biomedical5161-00-5022 (GC150085-10)51610050222023-11-27
00858325005596Gauthier Biomedical5161-00-5023 (GC155006-20)51610050232023-11-27
00858325005602Gauthier Biomedical5161-00-5024 (GC155006-10)51610050242023-11-27
00858325005619Gauthier Biomedical5161-00-5025 (GC150088-20)51610050252023-11-27
00858325005626Gauthier Biomedical5161-00-5026 (GC150088-10)51610050262023-11-27
00858325005633Gauthier Biomedical5161-00-5027 (GC155010-20)51610050272023-11-27
00858325005640Gauthier Biomedical5161-00-5028 (GC155010-10)51610050282023-11-27
00858325005657Gauthier Biomedical5161-00-5029 (G160249)51610050292023-11-27
00858325005800Gauthier Biomedical6231-31-022 (G700206)6231310222025-05-05
00858325005763Gauthier BiomedicalG851301G8513012025-03-03
00858325005770Gauthier BiomedicalG852404G8524042025-03-03
00858325005787Gauthier BiomedicalG119402G1194022025-03-03
00858325005794Gauthier BiomedicalG170402G1704022025-03-03
00858325005817Gauthier BiomedicalG912126G9121262025-03-03
00858325005824Gauthier BiomedicalG912128G9121282025-01-22
00858325005756Gauthier BiomedicalGC101211GC1012112024-11-26
00858325005206Gauthier BiomedicalG207163G2071632020-08-11
00858325005428Gauthier Biomedical5161-00-5000 (G908179)51610050002023-11-28
00858325005435Gauthier Biomedical5161-00-5001 (G908144)51610050012023-11-28

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08698940971454SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
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