FDA.reportPublic FDA data

Buxton BioMedical

Primary DI
B7685661320
Brand
Buxton BioMedical
Company
BUXTON BIOMEDICAL, INC.
Model
56-6132
Catalog number
56-6132
Device description
Buck-Gramcko Elevator
Published
2024-03-01
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7685661320PrimaryHIBCC0

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
B7685216080Buxton Biomedical, Inc52-160852-16082026-10-06
B7687419600Buxton Biomedical, Inc74-196074-19602026-10-06
B7687715080Buxton Biomedical, Inc77-150877-15082026-10-06
B7688399130Buxton Biomedical, Inc83-991383-99132026-10-06
B7688452230Buxton Biomedical, Inc84-522384-52232026-10-06
B7688452240Buxton Biomedical, Inc84-522484-52242026-10-06
B76884751630Buxton Biomedical, Inc847-5163847-51632026-10-06
B7688632520Buxton Biomedical, Inc86-325286-32522026-10-06
B7688652520Buxton Biomedical, Inc86-525286-52522026-10-06
B76886844120Buxton Biomedical, Inc868-4412868-44122026-10-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995266936Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00810130207572MSIModern Surgical Instruments LLCGAD2026-10-15
00810130207589MSIModern Surgical Instruments LLCGAD2026-10-15
00810220800645Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800652Adler Instrument CompanyAdler, Inc.GAD2026-10-15
00810220800669Adler Instrument CompanyAdler, Inc.GAD2026-10-15
03661219013341LANDANGERLANDANGERGAD2026-10-15
10724995269316Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
10724995269323Snowden-PencerSTERIS Deutschland GmbHGAD2026-10-15
00190776434953MillenniumAvalign Technologies, Inc.GAD2026-10-14
00192896123922Knurled NutSONTEC INSTRUMENTS, INC.GAD2026-10-14
00842102116513DynaTrac Retractor FramesFLEXBAR MACHINE CORPORATIONGAD2026-10-14
00190776434632MillenniumAvalign Technologies, Inc.GAD2026-10-12
00190776434663MillenniumAvalign Technologies, Inc.GAD2026-10-12
00190776434700MillenniumAvalign Technologies, Inc.GAD2026-10-12
04058749044249NAFehling Instruments GmbH & Co. KGGAD2026-10-12
G1415189430Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-10-12
00190776434144MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434205MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434212MillenniumAvalign Technologies, Inc.GAD2026-10-09
00190776434601MillenniumAvalign Technologies, Inc.GAD2026-10-09
00198506095849ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-09
00198506095856ELMED INCORPORATEDELMED INCORPORATEDGAD2026-10-09
00840277133717Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133922Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133939Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133946Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133953Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133960Innomed, Inc.INNOMED, INC.GAD2026-10-09
00840277133977Innomed, Inc.INNOMED, INC.GAD2026-10-09