FDA.reportPublic FDA data

STAPLIZER

Primary DI
10845854031742
Brand
STAPLIZER
Company
Conmed Corporation
Model
T116
Catalog number
T116
Device description
16mm STAPLE CARRIER
Published
2021-05-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRStaple, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K840566000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K840566000BONE STAPLING FIXATION SYS3M Company1984-11-23JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845854031742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084585403174210845854031742

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
1
Serial number
true
Manufacturing date on label
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
00815432028108DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2022-10-24
00815432026241HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04
00815432026258HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2022-01-04
B56217634WB0Memory StapleWishbone Medical, Inc.JDR2020-08-06
00815432027255DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-06-03
00815432026111DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026128DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026135HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026142HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026180HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026197HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026203HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026326DynaFORCECROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432026340HiMAX CCROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432028788MotoBAND™ CP DynaForce®CROSSROADS EXTREMITY SYSTEMSJDR2020-05-28
00815432028726MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028795MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028801MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028818MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2020-05-27
00815432028184DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-03-31
00815432028221DynaFORCE™CROSSROADS EXTREMITY SYSTEMSJDR2020-03-31
00815432027279DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432027286DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028115DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028122DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028139DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028146DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028153DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028160DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20
00815432028177DynaFORCE™ HiMaxCROSSROADS EXTREMITY SYSTEMSJDR2020-03-20