FDA.reportPublic FDA data

Gauthier Biomedical

Primary DI
00858325005695
Brand
Gauthier Biomedical
Company
GAUTHIER BIOMEDICAL, INC.
Model
5161-00-5051 (G601227)
Catalog number
5161005051
Device description
COMPRESSOR 5.5/6.0, PARALLEL
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
HWNInstrument, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858325005695PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858325005695008583250056958583250056950858325005695

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical distractor, internalA hand-held manual surgical instrument designed to invasively distract (force apart) two bone surfaces to enable a surgical procedure. It typically aids in fracture reduction by helping to temporarily stabilize bones prior to definitive surgical fixation. It typically consists of a central threaded spindle, a static endpiece and a sliding carriage that can be adjusted using spindle nuts to/from the endpiece to widen or shorten the gap; it facilitates the attachment of orthopaedic bone pins (Schanz screws) screwed into the bones to be distracted. It is typically used for multiple injuries when it is advantageous to perform procedures on a standard operating table. 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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