iBur 8431-009-040

GUDID 07613327501223

4.0mm Precision Round, Distal Bend

STRYKER CORPORATION

Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use Cranial bur, single-use
Primary Device ID07613327501223
NIH Device Record Keyf3f40ef2-e49c-4a92-b6c3-29c534d4df73
Commercial Distribution StatusIn Commercial Distribution
Brand NameiBur
Version Model Number8431-009-040
Catalog Number8431-009-040
Company DUNS196548481
Company NameSTRYKER CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com
Phone+0018002533210
EmailInst.Stryker.cs@Stryker.com

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 40 Degrees Celsius
Storage Environment Atmospheric PressureBetween 50 KiloPascal and 106 KiloPascal
Handling Environment Atmospheric PressureBetween 70 KiloPascal and 106 KiloPascal
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 10 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327501223 [Primary]

FDA Product Code

HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-20
Device Publish Date2021-08-12

On-Brand Devices [iBur]

076133275092293.0mm DIAMOND MATCH HEAD, DISTAL BEND
37613327501309Hub
37613327501293Angled Hub
076133275012784.0mm Diamond Round, Distal Bend
076133275012612.0mm Diamond Round, Distal Bend
076133275012473.0mm Precision Round, Distal Bend
076133275012303.0mm Diamond Round, Distal Bend
076133275012234.0mm Precision Round, Distal Bend
076133275012093.0mm Coarse Diamond Round, Distal Bend
076133275011933.0mm Precision Match Head, Distal Bend
076133275011865.0mm Coarse Diamond Round, Distal Bend
076133275011793.0mm Precision Round, Proximal Bend
076133275011554.0mm Coarse Diamond Round, Distal Bend
076133275011314.0mm Precision Round, Proximal Bend
076133275008132.5mm Diamond Match Head, Proximal Bend
076133275008063.0mm Diamond Match Head, Proximal Bend
076133275002572.5mm Precision Match Head, Distal Bend
076133274988513.0mm Precision Match Head, Proximal Bend

Trademark Results [iBur]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IBUR
IBUR
88659555 not registered Live/Pending
Stryker European Operations Limited
2019-10-18
IBUR
IBUR
77816853 4026612 Live/Registered
IBUR, LLC
2009-08-31

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