FDA.report

24K

Primary DI
30845854041424
Brand
24K
Company
Conmed Corporation
Model
C8115
Catalog number
C8115
Device description
24K AUTOCLAVABLE REMOTE CONTROL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HRXARTHROSCOPE

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30845854041424Direct MarkingGS10
10845854041420PrimaryGS10
20845854041427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3084585404142430845854041424
1084585404142010845854041420
2084585404142720845854041427

GMDN Terms

TermDefinition
Irrigation/lavage system remote controlA hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an irrigation/lavage system (e.g., arthroscopic irrigation/distention system, colonic lavage system) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.

Storage And Handling

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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20653405022951CONMEDFSR1370FSR13702026-03-24
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20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24
20653405024948CONMEDR324IIRA2R324IIRA22026-03-24
20653405034701CONMEDD8550D85502026-03-24

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04056702011987Autoclavable remote controlW.O.M. World of Medicine GmbHHRX2026-03-10
04056702011994Double pedal foot switchW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012014Tube set for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012038Tube set for suction, 2-lines, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012052Day use tube set for irrigation, pump part, 10 applicationsW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012076Patient tube for irrigation, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012090Tube set for vacuum, incl. filter, 30-day useW.O.M. World of Medicine GmbHHRX2026-03-10
04056702012113Tube set for suction, single-useW.O.M. World of Medicine GmbHHRX2026-03-10
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