FDA.report

Buxton BioMedical

Primary DI
B7685257820
Brand
Buxton BioMedical
Company
Buxton Biomedical Inc
Model
52-5782
Catalog number
52-5782
Device description
WeitlanerRet,105x25mm,2x3 blnt
Published
2023-07-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GAGStapler, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B7685257820PrimaryHIBCC0

GMDN Terms

TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods

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 DIBrandModelCatalogPublished
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B76885362280Buxton BioMedical853-6228853-62282025-12-31
B76885362360Buxton BioMedical853-6236853-62362025-12-31
B7682461610Buxton BioMedical24-616124-61612025-12-12
B768347375900Buxton BioMedical347-375-90347-375-902025-12-12
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B7685671280Buxton BioMedical56-712856-71282025-12-12
B7685216220Buxton BioMedical52-162252-16222025-11-13
B7687477000Buxton BioMedical74-770074-77002025-11-13
B7687771080Buxton BioMedical77-710877-71082025-11-13
B7687771100Buxton BioMedical77-711077-77102025-11-13
B7687771180Buxton BioMedical77-711877-71182025-11-13
B76884332520Buxton BioMedical843-3252843-32522025-11-13
B76885300040Buxton BioMedical853-0004853-00042025-11-13
B7682460370Buxton BioMedical24-603724-60372025-09-24
B7685255190Buxton BioMedical52-551952-55192025-09-24
B7685257320Buxton BioMedical52-573252-57322025-09-24
B7685410380Buxton BioMedical54-103854-10382025-09-24
B7685410410Buxton BioMedical54-104154-10412025-09-24

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00190776409500MillenniumAvalign Technologies, Inc.GAG2025-09-02
20705036043529ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043536ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20705036043543ETHICONETHICON ENDO-SURGERY, LLCGAG2025-08-22
20888277368290MEDLINE RENEWALMEDLINE INDUSTRIES, INC.GAG2025-02-14
20888277378879MEDLINEMEDLINE INDUSTRIES, INC.GAG2025-02-14
20884521827636EEACovidien LPGAG2025-02-07
20884521703732Tri-Staple 2.0Covidien LPGAG2024-11-29
20884521703756Tri-Staple 2.0Covidien LPGAG2024-11-29
20884521703770Tri-Staple 2.0Covidien LPGAG2024-11-29
10884521845497SigniaCovidien LPGAG2024-11-29
00851574008639AEONLEXINGTON MEDICAL, INC.GAG2024-05-24
00851574008356AEONLEXINGTON MEDICAL, INC.GAG2024-05-24
00851574008479AEONLEXINGTON MEDICAL, INC.GAG2024-05-24
20884521592985EEACovidien LPGAG2024-05-03
30705036027861Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
20705036027871Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
40705036027882Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
30705036027908Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
30705036030892Echelon Linear CutterETHICON ENDO-SURGERY, LLCGAG2024-04-15
20884521842677GIACovidien LPGAG2024-03-25
20884521842653GIACovidien LPGAG2024-03-19
20884521842660GIACovidien LPGAG2024-03-19
B7685255150Buxton BioMedicalBuxton Biomedical IncGAG2023-03-03
00304040063347Henry ScheinHENRY SCHEIN, INC.GAG2022-10-31
00304040070987Henry ScheinHENRY SCHEIN, INC.GAG2022-10-31
20705036034961ECHELONETHICON ENDO-SURGERY, LLCGAG2022-09-23
30705036034975ECHELONETHICON ENDO-SURGERY, LLCGAG2022-09-23
20705036034985ECHELONETHICON ENDO-SURGERY, LLCGAG2022-09-23
30705036034999ECHELONETHICON ENDO-SURGERY, LLCGAG2022-09-23