Primary Device ID | 07613327501155 |
NIH Device Record Key | d7899b5a-f873-4b77-b41c-d86d5d3800f4 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | iBur |
Version Model Number | 8431-013-040DC |
Catalog Number | 8431-013-040DC |
Company DUNS | 196548481 |
Company Name | STRYKER CORPORATION |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +0018002533210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +0018002533210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +0018002533210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +0018002533210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +0018002533210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +0018002533210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +0018002533210 |
Inst.Stryker.cs@Stryker.com | |
Phone | +0018002533210 |
Inst.Stryker.cs@Stryker.com |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -20 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Temperature | Between 10 Degrees Celsius and 27 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07613327501155 [Primary] |
HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-08-20 |
Device Publish Date | 2021-08-12 |
07613327509229 | 3.0mm DIAMOND MATCH HEAD, DISTAL BEND |
37613327501309 | Hub |
37613327501293 | Angled Hub |
07613327501278 | 4.0mm Diamond Round, Distal Bend |
07613327501261 | 2.0mm Diamond Round, Distal Bend |
07613327501247 | 3.0mm Precision Round, Distal Bend |
07613327501230 | 3.0mm Diamond Round, Distal Bend |
07613327501223 | 4.0mm Precision Round, Distal Bend |
07613327501209 | 3.0mm Coarse Diamond Round, Distal Bend |
07613327501193 | 3.0mm Precision Match Head, Distal Bend |
07613327501186 | 5.0mm Coarse Diamond Round, Distal Bend |
07613327501179 | 3.0mm Precision Round, Proximal Bend |
07613327501155 | 4.0mm Coarse Diamond Round, Distal Bend |
07613327501131 | 4.0mm Precision Round, Proximal Bend |
07613327500813 | 2.5mm Diamond Match Head, Proximal Bend |
07613327500806 | 3.0mm Diamond Match Head, Proximal Bend |
07613327500257 | 2.5mm Precision Match Head, Distal Bend |
07613327498851 | 3.0mm Precision Match Head, Proximal Bend |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
IBUR 88659555 not registered Live/Pending |
Stryker European Operations Limited 2019-10-18 |
IBUR 77816853 4026612 Live/Registered |
IBUR, LLC 2009-08-31 |