FDA.reportPublic FDA data

Buxton BioMedical

Primary DI
B7682461370
Brand
Buxton BioMedical
Company
Buxton Biomedical Inc
Model
24-6137
Catalog number
24-6137
Device description
Darrach Retractor, 360 x 25 mm
Published
2022-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7682461370PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
B7684612300Buxton BioMedical46-123046-12302026-06-02
B7685410360Buxton BioMedical54-103654-10362026-06-02
B7685631130Buxton BioMedical56-311356-31132026-06-02
B7687425470Buxton BioMedical74-254774-25472026-06-02
B7687425570Buxton BioMedical74-255774-25572026-06-02
B7688371010Buxton BioMedical83-710183-71012026-06-02
B7688532051730Buxton BioMedical853-20-5173853-20-51732026-06-02
B7688532061040Buxton BioMedical853-20-6104853-20-61042026-06-02
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338005467FreerELLIQUENCE, LLCGEG2026-06-01
G383S1061WM8535437SURJEXSURJEXGEG2026-05-31
G4251902480My MedicalMy Medical Store LLCGEG2026-05-04
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