FDA.reportPublic FDA data

CONMED REFLEX

Primary DI
20653405047091
Brand
CONMED REFLEX
Company
Conmed Corporation
Model
8935
Catalog number
8935
Device description
CONMED REFLEX RHS SINGLE USE, RELOADABLE, ROTATING HEAD SKIN STAPLER
Published
2021-10-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZQCLIP, REMOVABLE (SKIN)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZQClip, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30653405047098PackageGS11Not in Commercial Distribution
20653405047091PrimaryGS10
00653405047097Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3065340504709830653405047098
2065340504709120653405047091
00653405047097006534050470976534050470970653405047097

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
6
Premarket exempt
true
Lot or batch
true
Expiration 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
00842331160783Novo Surgical Inc. NOVO SURGICAL, INC.FZQ2022-11-13
00842331163944Novo Surgical Inc. NOVO SURGICAL, INC.FZQ2022-11-13
20653405037238REFLEXConmed CorporationFZQ2021-10-14
20653405037252REFLEXConmed CorporationFZQ2021-10-14
00653405037234REFLEXConmed CorporationFZQ2021-10-14
00653405037258REFLEXConmed CorporationFZQ2021-10-14
30653405047098CONMED REFLEXConmed CorporationFZQ2021-10-14
00850010207094BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
00850010207193BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
10850010207091BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
20653405036927REFLEXConmed CorporationFZQ2020-11-13
20653405036958REFLEXConmed CorporationFZQ2020-11-13
20653405036989REFLEXConmed CorporationFZQ2020-11-13
20653405037016REFLEXConmed CorporationFZQ2020-11-13
20653405048388REFLEXConmed CorporationFZQ2020-11-13
20653405050596REFLEXConmed CorporationFZQ2020-11-13
20653405050602REFLEXConmed CorporationFZQ2020-11-13
20653405050893REFLEXConmed CorporationFZQ2020-11-13
10653405036920REFLEXConmed CorporationFZQ2020-11-13
10653405036951REFLEXConmed CorporationFZQ2020-11-13
10653405036982REFLEXConmed CorporationFZQ2020-11-13
10653405037019REFLEXConmed CorporationFZQ2020-11-13
10653405048381REFLEXConmed CorporationFZQ2020-11-13
10653405050599REFLEXConmed CorporationFZQ2020-11-13
10653405050605REFLEXConmed CorporationFZQ2020-11-13
10653405050896REFLEXConmed CorporationFZQ2020-11-13
04046826020392MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826020408MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826020415MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826020422MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24