FDA.report

Buxton BioMedical

Primary DI
B7685611320
Brand
Buxton BioMedical
Company
Buxton Biomedical Inc
Model
56-1132
Catalog number
56-1132
Device description
Ikuta Bone Clamp, str, 1.6mm
Published
2023-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GDJClamp, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B7685611320PrimaryHIBCC0

GMDN Terms

TermDefinition
Bone holding forcepsA manual surgical instrument designed to grasp and hold a bone during an open surgical procedure. It is typically strongly constructed with a scissors-like design, which may or may not be self-retaining, and with ring handles or curved shank handles. It is made of high-grade stainless steel and is available in various sizes. The working end can have a wide variety of jaws designs, e.g., curved serrated jaws, straight toothed jaws, or profiled wrench-like jaws with grooves to provide extra grip of the bone. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
808385207
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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B76885362280Buxton BioMedical853-6228853-62282025-12-31
B76885362360Buxton BioMedical853-6236853-62362025-12-31
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B7687771080Buxton BioMedical77-710877-71082025-11-13
B7687771100Buxton BioMedical77-711077-77102025-11-13
B7687771180Buxton BioMedical77-711877-71182025-11-13
B76884332520Buxton BioMedical843-3252843-32522025-11-13
B76885300040Buxton BioMedical853-0004853-00042025-11-13
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B7685257320Buxton BioMedical52-573252-57322025-09-24
B7685410380Buxton BioMedical54-103854-10382025-09-24
B7685410410Buxton BioMedical54-104154-10412025-09-24

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