FDA.reportPublic FDA data

Buxton BioMedical

Primary DI
B7685640230
Brand
Buxton BioMedical
Company
BUXTON BIOMEDICAL, INC.
Model
56-4023
Catalog number
56-4023
Device description
Flush Wire Cutter, 160 mm
Published
2023-07-07
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
HXZCutter, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7685640230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wire cutterA heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. 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
00190776061890Avalign TechnologiesAvalign Technologies, Inc.HXZ2026-10-14
00190776430979MillenniumAvalign Technologies, Inc.HXZ2026-09-18
00190776430986MillenniumAvalign Technologies, Inc.HXZ2026-09-18
00190776426569MillenniumAvalign Technologies, Inc.HXZ2026-08-19
00190776426668MillenniumAvalign Technologies, Inc.HXZ2026-08-19
00850088713299PRINCETONPrinceton Medical Group, Inc.HXZ2026-08-14
B8034606210ORTHOMEDORTHO-MED, INC.HXZ2026-07-14
B8034606250ORTHOMEDORTHO-MED, INC.HXZ2026-07-14
00810207784005Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784012Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784029Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
20757770457766Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457773Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457780Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
08800089423880Surgical InstrumentJeil Medical CorporationHXZ2026-04-09
00810118108051NuSmile Hard Wire CutterNUSMILE, LTD.HXZ2026-04-08
00192896122994Table Top Rod CutterSONTEC INSTRUMENTS, INC.HXZ2026-03-31
00841506142364GeminusSKELETAL DYNAMICS L.L.C.HXZ2026-01-21
00192896122529Crimper/CutterSONTEC INSTRUMENTS, INC.HXZ2025-11-21
00199150050888Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXZ2025-11-20
D90980001641ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D90980001651ORTHO ARCHOrtho Arch Company IncHXZ2025-09-15
D9098000331SPECTRUMOrtho Arch Company IncHXZ2025-09-15
D90980021311RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021412RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021513RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021715RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021816RAZOROrtho Arch Company IncHXZ2025-09-15
D90980021917RAZOROrtho Arch Company IncHXZ2025-09-15
D90980022312RAZOROrtho Arch Company IncHXZ2025-09-15