FDA.reportPublic FDA data

Buxton BioMedical

Primary DI
B7687834600
Brand
Buxton BioMedical
Company
BUXTON BIOMEDICAL, INC.
Model
78-3460
Catalog number
78-3460
Device description
Cobb Elevator knurl hndl,10mm
Published
2023-01-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEDBrush, Dermabrasion, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEDBrush, Dermabrasion, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7687834600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Sterilization Methods#

Method table
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B7683361430Buxton BioMedical33-614333-61432026-06-19
B7683363220Buxton BioMedical33-632233-63222026-06-19
B7685215250Buxton BioMedical52-152552-15252026-06-19
B7685231210Buxton BioMedical52-312152-31212026-06-19
B7685490130Buxton BioMedical54-901354-90132026-06-19
B7687417030Buxton BioMedical74-170374-17032026-06-19
B7685252430Buxton BioMedical52-524352-52432026-06-05
B76884850220Buxton BioMedical848-5022848-50222026-06-05
B7688532051620Buxton BioMedical853-20-5162853-20-51622026-06-05
B7688532051630Buxton BioMedical853-20-5163853-20-51632026-06-05
B7688532051720Buxton BioMedical853-20-5172853-20-51722026-06-05
B7688654120Buxton BioMedical86-541286-54122026-06-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344029686MEDLINEMEDLINE INDUSTRIES, INC.GED2024-07-11
30197344029680MEDLINEMEDLINE INDUSTRIES, INC.GED2024-07-11
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00630094188928Bioseal Inc.BIOSEALGED2023-10-05
00630094188935Bioseal Inc.BIOSEALGED2023-10-05
10630094188253Bioseal Inc.BIOSEALGED2023-10-05
10630094188260Bioseal Inc.BIOSEALGED2023-10-05
10630094188307Bioseal Inc.BIOSEALGED2023-10-05
10630094188406Bioseal Inc.BIOSEALGED2023-10-05
10630094188703Bioseal Inc.BIOSEALGED2023-10-05
10630094188901Bioseal Inc.BIOSEALGED2023-10-05
10630094188918Bioseal Inc.BIOSEALGED2023-10-05
10630094188925Bioseal Inc.BIOSEALGED2023-10-05
10630094188932Bioseal Inc.BIOSEALGED2023-10-05
00850019947847Dermal Cooling SystemR2 Technologies, Inc.GED2023-06-09
00850019947878Dermal Cooling SystemR2 Technologies, Inc.GED2023-06-09
00850019947632Dermal Cooling SystemR2 DERMATOLOGY INC.GED2023-06-09
00827002485273CookCOOK INCORPORATEDGED2020-10-02
00860371002306Norsen Debrider, SterileBEL-MED, INC.GED2019-05-29