FDA.reportPublic FDA data

Gauthier Biomedical

Primary DI
00858325005565
Brand
Gauthier Biomedical
Company
GAUTHIER BIOMEDICAL, INC.
Model
5161-00-5020 (GC150086-10)
Catalog number
5161005020
Device description
ROD ROTATOR WRENCH 5.5/6.0
Published
2023-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXCWrench

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXCWrenchOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858325005565PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858325005565008583250055658583250055650858325005565

GMDN Terms#

Term, Definition table
TermDefinition
Surgical torque wrench, reusableA hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
015227072
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
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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Primary DI, Brand, Company table
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10889981437794SpecialsSeaspine Orthopedics CorporationHXC2025-10-17
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10886982195722NASynthes GmbHHXC2019-02-21
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