FDA.report

Buxton BioMedical

Primary DI
B7685810200
Brand
Buxton BioMedical
Company
Buxton Biomedical Inc
Model
58-1020
Catalog number
58-1020
Device description
Thumkin™, small
Published
2023-05-26
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
true

Related Records

Product Codes

CodeName
ILHSplint, Hand, And Components

Product Code Classifications

CodeDeviceSpecialtyClass
ILHSplint, Hand, And ComponentsPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B7685810200PrimaryHIBCC0

GMDN Terms

TermDefinition
Hand/finger splint, single-useA prefabricated (non-customized) wearable rigid or semi-rigid device intended to immobilize an injured/diseased hand and/or finger to support, align or prevent injury during the healing process. It is applied externally to the hand/finger/wrist and typically held in place with self-retaining fasteners (e.g., Velcro bands) or bandage wraps. This is a single-use device.

Sterilization Methods

Method

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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B7688441020Buxton BioMedical84-410284-41022025-12-31
B7688457751630Buxton BioMedical845-77-5163845-77-51632025-12-31
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
B7685612810Buxton BioMedical56-128156-12812025-12-12
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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