FDA.reportPublic FDA data

HALL

Primary DI
10653405005513
Brand
HALL
Company
Conmed Corporation
Model
L3500
Catalog number
L3500
Device description
HALL Small Bone Lithium Power Unit Adaptor
Published
2023-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HABSAW, POWERED, AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HABSaw, Powered, And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30653405005517Direct MarkingGS10
20653405005510PreviousGS10
10653405005513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3065340500551730653405005517
2065340500551020653405005510
1065340500551310653405005513

GMDN Terms#

Term, Definition table
TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-4 Degrees Fahrenheit158 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20653405546501Y-KnotlessTM FlexYKF-GYKF-G2026-02-06
20653405990724Y-KnotlessTM FlexYKF-WYKF-W2026-02-06
10845854027851GENESYS PRESSFT, HI-FINB211NB2112015-10-24
10845854027875GENESYS PRESSFT, HI-FINB212NB2122015-10-24
10845854027882GENESYS PRESSFT, HI-FINB261NB2612015-10-24
10845854027905GENESYS PRESSFT, HI-FINB262NB2622015-10-24
10845854061718LASEADAPTLA3010EY10LA3010EY102020-06-01
20653405014147CONMED7-809-47-809-42016-09-24
20653405014154CONMED7-809-57-809-52016-09-24
20653405014178CONMED7-809-77-809-72016-09-24
20845854081584VIROSAFEVSOH002VSOH0022020-06-27
30653405061582DetachaTip3-10093-10092016-09-24
30653405061766DetachaTipIII3-43183-43182016-09-24
20845854649975ParadigmPRBSPRBS2022-02-08
20845854649982ParadigmPRBHPRBH2022-02-08
20845854655501Argo KnotlessKBC475-KITKBC475-KIT2026-09-25
20845854655518Argo KnotlessK475-KITK475-KIT2026-09-25
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260472037TRAUSSaeshin Precision Co., Ltd.HAB2026-05-07
08809260471924TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471931TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471948TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471955TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471962TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471979TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471986TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260471993TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472006TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472013TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260472020TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473041TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473058TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473065TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473072TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473089TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473096TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
08809260473102TRAUSSaeshin Precision Co., Ltd.HAB2026-05-06
30653405990738Hall® Titan™Conmed CorporationHAB2025-12-29
30653405990745Hall® Titan™Conmed CorporationHAB2025-12-29
10653405005711HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005728HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005735HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005742HALL MICROFREEConmed CorporationHAB2023-10-12
10653405005759HALL MICROFREEConmed CorporationHAB2023-10-12
00885556826676First Choice DRUJ SystemSmith & Nephew, Inc.HAB2023-08-02
00885556856840Ascension MCP Joint ReplacementSmith & Nephew, Inc.HAB2023-08-02
00885556857663NuGrip CMCSmith & Nephew, Inc.HAB2023-08-02
00885556858479PyroCarbon PIP Total Joint SystemSmith & Nephew, Inc.HAB2023-08-02