FDA.reportPublic FDA data

PENADAPT

Primary DI
30845854080799
Brand
PENADAPT
Company
Conmed Corporation
Model
PA2010BCB
Catalog number
PA2010BCB
Device description
PenAdapt Electrosurgical Pencil Adapter 10 ft (30.5 m) tubing
Published
2020-06-01
Public version status
Update
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
30845854080799PackageGS110In Commercial Distribution
00815198012519PreviousGS10
20845854080792PrimaryGS10
00845854080798Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3084585408079930845854080799
00815198012519008151980125198151980125190815198012519
2084585408079220845854080792
00845854080798008458540807988458540807980845854080798

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.

Sterilization Methods#

Method table
Method
Radiation Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
10
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10705036046523MegadyneETHICON ENDO-SURGERY, LLCFYD2026-05-27
10860012888808Flamingo Funnel (miniSQUAIR) - LargeNASCENT SURGICAL, LLCFYD2026-05-01
10860012888815Flamingo Funnel (microSQUAIR) - MediumNASCENT SURGICAL, LLCFYD2026-05-01
10860012888822Flamingo Funnel (nanoSQUAIR) - Small NASCENT SURGICAL, LLCFYD2026-05-01
20845854081751CONMED BUFFALO FILTERConmed CorporationFYD2024-03-25
10193489085341MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10193489085358MedlineMEDLINE INDUSTRIES, INC.FYD2023-02-22
10845854600085Smoke Shark IIIConmed CorporationFYD2021-02-12
10845854600092Smoke Shark IIIConmed CorporationFYD2021-02-12
20845854600105Smoke Shark IIIConmed CorporationFYD2021-01-20
40845854081830VIROSAFEConmed CorporationFYD2021-01-20
10845854082898BOVIE SharkSkinConmed CorporationFYD2021-01-07
40845854053127MEGADYNE MICROSAFEConmed CorporationFYD2020-12-08
10845854053096MINIVACConmed CorporationFYD2020-11-20
10845854053102MINIVACConmed CorporationFYD2020-11-20
20845854082802VIROSAFEConmed CorporationFYD2020-11-02
20845854081775OR-VACConmed CorporationFYD2020-10-23
20845854081058OR-VACConmed CorporationFYD2020-10-21
30845854081024OR-VACConmed CorporationFYD2020-10-21
30845854081031OR-VACConmed CorporationFYD2020-10-21
30845854081048OR-VACConmed CorporationFYD2020-10-21
30845854081680NAConmed CorporationFYD2020-10-14
20845854081706BOWAConmed CorporationFYD2020-09-30
20845854053192PENADAPTConmed CorporationFYD2020-09-17
20845854061814BOWAConmed CorporationFYD2020-09-15
20845854061821BOWAConmed CorporationFYD2020-09-15
20845854060015VIROSAFEConmed CorporationFYD2020-09-13
20845854081805HarmonyAIRConmed CorporationFYD2020-09-11
30845854053182BOWAConmed CorporationFYD2020-09-05
10614559104521MegadyneMEGADYNE MEDICAL PRODUCTS, INC.FYD2020-09-02