FDA.reportPublic FDA data

CONMED REFLEX

Primary DI
30653405047098
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
30653405047098PackageGS11In 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
20653405037573CONMEDPCD10PCD102016-09-24
10653405063797CONMED75200752002026-03-24
00845854035590CONCEPTESA-5190ESA-51902026-03-24
10845854041116POWERPROPRO2000PRO20002026-03-24
10845854041291CONMEDLS7501LS75012026-03-24
00653405014952POOLE903507090350702026-03-24
20653405017759CONMEDD8324D83242026-03-24
20653405017766CONMEDD8324IID8324II2026-03-24
20653405019777CONMEDDA36-03DA36-032026-03-24
20653405022821CONMEDFSR1303FSR13032026-03-24
20653405022838CONMEDFSR1311FSR13112026-03-24
20653405022951CONMEDFSR1370FSR13702026-03-24
20653405023057CONMEDFSR1534FSR15342026-03-24
20653405023071CONMEDFSR1539FSR15392026-03-24
20653405023163CONMEDFSR1590FSR15902026-03-24
20653405023170CONMEDFSR1590-20FSR1590-202026-03-24
20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24

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
00653405037234REFLEXConmed CorporationFZQ2021-10-14
00653405037258REFLEXConmed CorporationFZQ2021-10-14
10850010207091BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2021-03-01
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
04046826314606MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314613MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314620MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314637MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314644MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314651MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
04046826314668MediconMedicon eG. Chirurgiemechaniker-GenossenschaftFZQ2020-09-24
10850010207176BandGrip® Micro-Anchor® ClosureBANDGRIP INC.FZQ2020-07-27
04038653337378AESCULAPAesculap AGFZQ2020-04-17
04038653337385AESCULAPAesculap AGFZQ2020-04-17
04038653337392AESCULAPAesculap AGFZQ2020-04-17
04038653337408AESCULAPAesculap AGFZQ2020-04-17
04038653337415AESCULAPAesculap AGFZQ2020-04-17
04038653337422AESCULAPAesculap AGFZQ2020-04-17
04038653337439AESCULAPAesculap AGFZQ2020-04-17
10850010207138BandGrip® Micro-Anchor® Skin ClosureBANDGRIP INC.FZQ2020-03-25
30850010207071BandGrip® Micro-Anchor® ClosureBANDGRIP INC.FZQ2020-03-24