FDA.reportPublic FDA data

SURGAIRTOME TWO

Primary DI
20845854018924
Brand
SURGAIRTOME TWO
Company
Conmed Corporation
Model
00505800100
Catalog number
00505800100
Device description
SURGAIRTOME TWO HANDPIECE
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSZINSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K781979000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K781979000SURGAIRTOME TWOAmerican Sterilizer Co.1978-12-20HSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30845854018921Direct MarkingGS10
20845854018924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084585401892130845854018921
2084585401892420845854018924

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system handpiece, sawing, pneumaticA pneumatically-powered, hand-held device that consists of a motorized handpiece that provides sagittal, oscillating, or reciprocating movement for attachable serrated blades to cut through hard/tough tissue during surgery. The device may be of the micro or macro design and is typically powered by a compressed gas [e.g., surgical-grade air or nitrogen (N2)]. This is a reusable device.

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
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20653405546501Y-KnotlessTM FlexYKF-GYKF-G2026-02-06
20653405990724Y-KnotlessTM FlexYKF-WYKF-W2026-02-06
10845854027851GENESYS PRESSFT, HI-FINB211NB2112015-10-24
10845854027875GENESYS PRESSFT, HI-FINB212NB2122015-10-24
10845854027882GENESYS PRESSFT, HI-FINB261NB2612015-10-24
10845854027905GENESYS PRESSFT, HI-FINB262NB2622015-10-24
10845854061718LASEADAPTLA3010EY10LA3010EY102020-06-01
20653405014147CONMED7-809-47-809-42016-09-24
20653405014154CONMED7-809-57-809-52016-09-24
20653405014178CONMED7-809-77-809-72016-09-24
20845854081584VIROSAFEVSOH002VSOH0022020-06-27
30653405061582DetachaTip3-10093-10092016-09-24
30653405061766DetachaTipIII3-43183-43182016-09-24
20845854649975ParadigmPRBSPRBS2022-02-08
20845854649982ParadigmPRBHPRBH2022-02-08
20845854655501Argo KnotlessKBC475-KITKBC475-KIT2026-09-25
20845854655518Argo KnotlessK475-KITK475-KIT2026-09-25
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150001989MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2026-03-09
10845854028636POWERPROConmed CorporationHSZ2023-09-01
10845854036198POWERPROConmed CorporationHSZ2023-09-01
10845854036204POWERPROConmed CorporationHSZ2023-09-01
30845854083950CONMEDConmed CorporationHSZ2022-06-06
00763000374730Midas Rex MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2021-05-21
10845854028384POWERPROConmed CorporationHSZ2021-04-19
10886982186041NASynthes GmbHHSZ2019-12-27
10886982186126NASynthes GmbHHSZ2019-12-27
10886982186317NASynthes GmbHHSZ2019-12-27
10886982186355NASynthes GmbHHSZ2019-12-27
10886982186430NASynthes GmbHHSZ2019-12-27
10886982186454NASynthes GmbHHSZ2019-12-27
10886982186478NASynthes GmbHHSZ2019-12-27
10886982186492NASynthes GmbHHSZ2019-12-27
10886982186515NASynthes GmbHHSZ2019-12-27
10886982186553NASynthes GmbHHSZ2019-12-27
10886982186645NASynthes GmbHHSZ2019-12-27
10886982186706NASynthes GmbHHSZ2019-12-27
10886982186775NASynthes GmbHHSZ2019-12-27
10886982186850NASynthes GmbHHSZ2019-12-27
10886982186874NASynthes GmbHHSZ2019-12-27
10886982185914NASynthes GmbHHSZ2019-12-26
10886982185976NASynthes GmbHHSZ2019-12-26
10886982186034NASynthes GmbHHSZ2019-12-26
10886982186119NASynthes GmbHHSZ2019-12-26
10886982186201NASynthes GmbHHSZ2019-12-26
10886982186218NASynthes GmbHHSZ2019-12-26
10886982186249NASynthes GmbHHSZ2019-12-26
10886982186270NASynthes GmbHHSZ2019-12-26