FDA.reportPublic FDA data

SharkSkin

Primary DI
30845854082892
Brand
SharkSkin
Company
Conmed Corporation
Model
SS95-1
Catalog number
SS95-1
Device description
Electrosurgical Pencil Adapter
Published
2021-01-07
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
FYDAPPARATUS, EXHAUST, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYDApparatus, Exhaust, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30845854082892PackageGS120In Commercial Distribution
10845854082898PrimaryGS10
00845854082891Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084585408289230845854082892
1084585408289810845854082898
00845854082891008458540828918458540828910845854082891

GMDN Terms#

Term, Definition table
TermDefinition
Surgical plume evacuation system tubeA sterile, long, hollow cylinder which, as part of a surgical smoke evacuation system, is used to capture and conduct to exhaust the plume generated during open surgical procedures in which there is tissue ablation (e.g., laser surgery, electrocautery, electrosurgical diathermy device). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
20
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
false
Expiration date on label
true
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
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
10705036046523MegadyneMEGADYNE MEDICAL PRODUCTS, INC.FYD2025-06-18
30653405990196PlumeSafe® X5™Conmed CorporationFYD2024-08-13
10653405987550PlumeSafe® X5™Conmed CorporationFYD2024-08-12
10653405987994PlumeSafe® X5™Conmed CorporationFYD2024-08-12
10653405988007PlumeSafe® X5™Conmed CorporationFYD2024-08-12
30653405987561PlumeSafe® X5™Conmed CorporationFYD2024-08-12
30653405988018PlumeSafe® X5™Conmed CorporationFYD2024-08-12
00845854081757CooperSurgicalConmed CorporationFYD2024-03-25
00845854081641PLUMEGUARDConmed CorporationFYD2023-12-05
00845854081924CONMEDConmed CorporationFYD2023-12-05
30845854053106MINIVACConmed CorporationFYD2023-12-01
00845854080965CONMEDConmed CorporationFYD2023-12-01
30845854081147CYNOSUREConmed CorporationFYD2023-06-16
00817688021902Crystal VisionI.C. MEDICAL, INC.FYD2023-03-06
30193489085345MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
20193489085355MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
00817183020660NEBULAE SRS Tubing SetNORTHGATE TECHNOLOGIES INC.FYD2023-02-14
00817183020684NEBULAE SRS Laparoscopic Surgical PumpNORTHGATE TECHNOLOGIES INC.FYD2023-02-14
00840319734520Hayden MedicalHayden Medical, Inc.FYD2022-09-12
00840319734537Hayden MedicalHayden Medical, Inc.FYD2022-09-12
10653405002543NAConmed CorporationFYD2022-06-02
30653405988124Foot switch for FUMOVAC 900Conmed CorporationFYD2022-03-30
20845854082543Pneumatic Footswitch for PlumeVac™ Smoke Plume EvacuatorConmed CorporationFYD2021-12-20
30845854081116CYNOSUREConmed CorporationFYD2021-11-26
10845854648599TeleVac2Conmed CorporationFYD2021-11-08
30653405987622OR-VACConmed CorporationFYD2021-10-27
00817688022978STERISI.C. MEDICAL, INC.FYD2021-10-19
00817688022985STERISI.C. MEDICAL, INC.FYD2021-10-19
00817688023005STERISI.C. MEDICAL, INC.FYD2021-10-19
00817688023012STERISI.C. MEDICAL, INC.FYD2021-10-19