FDA.report

NA

Primary DI
30845854023581
Brand
NA
Company
Conmed Corporation
Model
5057-040
Catalog number
5057-040
Device description
REPEAT STERNOTOMY SAW
Published
2016-09-24
Public version status
Update
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
GETMOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications

CodeDeviceSpecialtyClass
GETMotor, Surgical Instrument, Pneumatic PoweredGeneral, Plastic Surgery1
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30845854023581Direct MarkingGS10
10845854023587PrimaryGS10
20845854023584PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3084585402358130845854023581
1084585402358710845854023587
2084585402358420845854023584

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
true
Serial number
false
Manufacturing date on label
false
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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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
20653405024948CONMEDR324IIRA2R324IIRA22026-03-24
20653405034701CONMEDD8550D85502026-03-24

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