FDA.reportPublic FDA data

Gauthier Biomedical

Primary DI
00858325005688
Brand
Gauthier Biomedical
Company
GAUTHIER BIOMEDICAL, INC.
Model
5161-00-5048 (G919509)
Catalog number
5161005048
Device description
TORQUE LIMITER, RATCHET 11.3NM
Published
2023-10-18
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
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
00858325005688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858325005688008583250056888583250056880858325005688

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
Serial number
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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10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
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00763000837198Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-18
00199150041183N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00199150076024Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00763000891329Medtronic Reusable Instruments & AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-17
00840314263636gSourceGSOURCE LLCLXH2026-07-17
00840314264190gSourceGSOURCE LLCLXH2026-07-17
00840314264268gSourceGSOURCE LLCLXH2026-07-17
00840314264404gSourceGSOURCE LLCLXH2026-07-17
00840314264473gSourceGSOURCE LLCLXH2026-07-17
00840314264541gSourceGSOURCE LLCLXH2026-07-17
00840314264619gSourceGSOURCE LLCLXH2026-07-17
00840314264688gSourceGSOURCE LLCLXH2026-07-17