FDA.reportPublic FDA data

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
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
GAGStapler, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAGStapler, SurgicalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7685257820PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 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
00190776431129MillenniumAvalign Technologies, Inc.GAG2026-09-21
10884521703827Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703834Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703841Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703858Tri-Staple 2.0Covidien LPGAG2026-08-09
10884521703797Tri-Staple 2.0Covidien LPGAG2026-07-31
10884521703810Tri-Staple 2.0Covidien LPGAG2026-07-31
16953886000118TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000125TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000132TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000149TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000156TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000163TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000170TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000187TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000194TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000200TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000217TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000224TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000231TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000248TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000255TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000262TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000279TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000286TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000293TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000309TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000316TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000323TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27
16953886000361TOUCHSTONETouchstone International Medical Science Co., Ltd.GAG2026-07-27