FDA.report

NA

Primary DI
30845854013216
Brand
NA
Company
Conmed Corporation
Model
5059-005
Catalog number
5059-005
Device description
STERNUM SAW HANDPIECE
Published
2020-09-24
Public version status
New
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
KFKSAW, PNEUMATICALLY POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
KFKSaw, Pneumatically PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30845854013216Direct MarkingGS10
20845854013219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3084585401321630845854013216
2084585401321920845854013219

GMDN Terms

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.

Storage And Handling

TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius70 Degrees Celsius
Storage Environment Temperature-40 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
true
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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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 DIBrandCompanyProduct codePublished
10845854013298NAConmed CorporationKFK2021-10-05
10845854023600NAConmed CorporationKFK2021-10-05
10845854013267NAConmed CorporationKFK2020-09-24
10845854023617NAConmed CorporationKFK2020-09-24
00643169797208Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-13
00643169797253Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-06
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00643169797147Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797154Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797161Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797178Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
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00643169797222Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
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00643169797246Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
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00643169797307Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797314Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
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00643169796942Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31
00643169796959Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31