FDA.reportPublic FDA data

NA

Primary DI
10653405014218
Brand
NA
Company
Conmed Corporation
Model
700
Catalog number
700
Device description
REUSABLE ELECTRODE KIT FOR USE WITH HYFRECATOR
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K800617000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K800617000HYFRECATOR, #733Birtcher Corp.1980-05-02GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10653405014218Direct MarkingGS10
30653405014212PackageGS15In Commercial Distribution
20653405014215PrimaryGS10
00653405014211Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1065340501421810653405014218
3065340501421230653405014212
2065340501421520653405014215
00653405014211006534050142116534050142110653405014211

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery electrosurgical electrode, monopolar, reusableAn invasive, monopolar, electrical conductor intended to be attached to an electrosurgical handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity085 Percent (%) Relative Humidity
Handling Environment Humidity0 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Handling Environment Temperature29 Degrees Fahrenheit149 Degrees Fahrenheit
Handling Environment Temperature34 Degrees Celsius65 Degrees Celsius
Storage Environment Humidity5 Percent (%) Relative Humidity70 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit90 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM

Regulatory Flags#

DUNS number
071595540
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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

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

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