FDA.reportPublic FDA data

Buxton BioMedical

Primary DI
B7685290200
Brand
Buxton BioMedical
Company
BUXTON BIOMEDICAL, INC.
Model
52-9020
Catalog number
52-9020
Device description
Hemo f/dissec & suture holding
Published
2023-03-24
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
HRQHemostat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7685290200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
00810143909197SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909265SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909302SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909616SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931777SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931784SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931791SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931807SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931814SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931906SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931920SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931937SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931944SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931951SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931968SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212935089SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143907438SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908725SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908732SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908749SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908756SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143909722SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143909739SURGIPROSSurgipros, LLCHRQ2026-07-30
00840183532321BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00840183533076BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00810055258567Surgical DesignSurgical Design, Inc.HRQ2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.HRQ2026-06-22
05060212051103Crile Artery Forceps, 145mm StraightDTR MEDICAL LIMITEDHRQ2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatDTR MEDICAL LIMITEDHRQ2026-06-10
05060411984639Baby Overholt Artery Forceps Curved, 140mmDTR MEDICAL LIMITEDHRQ2026-06-10