FDA.reportPublic FDA data

Buxton BioMedical

Primary DI
B7685720100
Brand
Buxton BioMedical
Company
Buxton Biomedical Inc
Model
57-2010
Catalog number
57-2010
Device description
Sterilizing Case 15x10x0.75
Published
2024-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7685720100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Device sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
808385207
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B7681901210Buxton BioMedical190-121190-1212023-07-07
B7683439140Buxton BioMedical34-391434-39142026-04-24
B7685674460Buxton BioMedical56-744656-74462026-04-24
B7685676080Buxton BioMedical56-760856-76082026-04-24
B7685677060Buxton BioMedical56-770656-77062026-04-24
B7682462200Buxton BioMedical24-622024-62202026-04-23
B7683434130Buxton BioMedical34-341334-34132026-04-23
B7687417000Buxton BioMedical74-170074-17002026-04-23
B7687684070Buxton BioMedical76-840776-84072026-04-23
B7688386020Buxton BioMedical83-860283-86022026-04-23
B7688441030Buxton BioMedical84-410384-41032026-04-23
B76884751040Buxton BioMedical847-5104847-51042026-04-23
B76884754320Buxton BioMedical847-5432847-54322026-04-23
B7688532061030Buxton BioMedical853-20-6103853-20-61032026-04-23
B7688532351120Buxton BioMedical853-23-5112853-23-51122026-04-23
B7688532351130Buxton BioMedical853-23-5113853-23-51132026-04-23
B7688650540Buxton BioMedical86-505486-50542026-04-23
B7688441020Buxton BioMedical84-410284-41022025-12-31
B7688457751630Buxton BioMedical845-77-5163845-77-51632025-12-31
B76885362280Buxton BioMedical853-6228853-62282025-12-31

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Primary DI, Brand, Company table
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ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
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