FDA.reportPublic FDA data

CONMED

Primary DI
10845854013298
Brand
CONMED
Company
Conmed Corporation
Model
00505900700
Catalog number
5059-07
Device description
STERNUM SAW WRENCH
Published
2021-10-05
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
KFKSAW, PNEUMATICALLY POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFKSaw, Pneumatically PoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K801737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K801737000STERNUM SAWAmsco Co.1980-08-20KFK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854013295Direct MarkingGS10
10845854013298PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084585401329520845854013295
1084585401329810845854013298

GMDN Terms#

Term, Definition table
TermDefinition
Electrical-only medical device connection cable, reusableA non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10845854023600CONMEDConmed CorporationKFK2021-10-05
20845854013219CONMEDConmed CorporationKFK2020-09-24
10845854013267CONMEDConmed CorporationKFK2020-09-24
10845854023617CONMEDConmed CorporationKFK2020-09-24
30845854013216NAConmed CorporationKFK2020-09-24
00643169797208Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-13
00643169797253Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-06
00643169797130Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797147Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797154Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797161Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797178Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797185Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797192Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797215Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797222Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797239Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797246Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797260Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797277Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797284Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797291Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797307Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797314Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797321Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797338Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169796911Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31
00643169796928Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31
00643169796935Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31
00643169796942Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31