FDA.reportPublic FDA data

CONMED

Primary DI
20845854013219
Brand
CONMED
Company
Conmed Corporation
Model
00505900500
Catalog number
5056-005
Device description
STERNUM SAW HANDPIECE
Published
2020-09-24
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
KFKSAW, PNEUMATICALLY POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFKSaw, Pneumatically PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30845854013216Direct MarkingGS10
20845854013219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084585401321630845854013216
2084585401321920845854013219

GMDN Terms#

Term, Definition table
TermDefinition
Bone/joint surgical power tool motorized handpiece/set, pneumaticA pneumatically-powered one-piece device or modular device collection designed to accept an endpiece(s) [e.g., drill bit, saw blade, bur] for drilling, cutting, and/or inserting procedures involving bones and tough tissues during a non-dental surgical procedure. It includes a pneumatic motor and one or more power tool attachments with a Jacobs chuck or quick-connect collet/adaptor at its distal end to connect the endpieces, and typically includes a pneumatic hose; the endpieces are not included. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20845854042004Y-KNOTYH01YH012015-10-24
20845854042028Y-KNOTYH02YH022015-10-24
10845854087534Infinity™QTSLQTSL2026-06-10
10845854087541Infinity™QTSRQTSR2026-06-10
10845854087558Infinity™RDBHRDBH2026-06-10
20653405990328Infinity™QTCRQTCR2026-06-10
20653405990366Infinity™ADB-0808ADB-08082026-06-10
20653405990373Infinity™ADB-0609ADB-06092026-06-10
20653405990380Infinity™ADB-0809ADB-08092026-06-10
20653405990397Infinity™ADB-0610ADB-06102026-06-10
20653405990403Infinity™ADB-0810ADB-08102026-06-10
20653405990410Infinity™ADB-0611ADB-06112026-06-10
20653405990427Infinity™DB-0808DB-08082026-06-10
20653405990434Infinity™DB-0609DB-06092026-06-10
20653405990441Infinity™DB-0809DB-08092026-06-10
20653405990458Infinity™DB-0610DB-06102026-06-10
20653405990465Infinity™DB-0810DB-08102026-06-10
20653405990472Infinity™DB-0611DB-06112026-06-10
10653405002765ABC® Bend-A-Beam®1340091340092016-09-24
10845854015506CONMEDC2630C26302015-12-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10845854013298CONMEDConmed CorporationKFK2021-10-05
10845854023600CONMEDConmed CorporationKFK2021-10-05
10845854013267CONMEDConmed CorporationKFK2020-09-24
10845854023617CONMEDConmed CorporationKFK2020-09-24
30845854013216NAConmed CorporationKFK2020-09-24
00643169797208Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-13
00643169797253Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-06
00643169797130Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
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
00643169797185Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797192Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797215Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797222Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797239Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797246Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797260Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797277Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797284Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797291Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797307Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797314Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797321Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169797338Triton®MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-08-01
00643169796911Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31
00643169796928Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31
00643169796935Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31
00643169796942Midas Rex™MEDTRONIC POWERED SURGICAL SOLUTIONSKFK2016-07-31