STRAIGHTSHOT®
GUDID 00643169588127
MICRODEBRIDER 1899200 M5 ROHS
MEDTRONIC XOMED, INC.
Multi-purpose surgical power tool system, line-powered Multi-purpose surgical power tool system, line-powered Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic Surgical power tool system control unit, pneumatic| Primary Device ID | 00643169588127 |
| NIH Device Record Key | da9691d3-ec1c-44ae-8f02-6cfe86679200 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | STRAIGHTSHOT® |
| Version Model Number | 1899200 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
| Storage Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 91 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169588127 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081277
FDA Product Code
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00643169588127]
Ethylene Oxide;Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2016-07-22 |
On-Brand Devices [STRAIGHTSHOT®]
| 00643169588127 | MICRODEBRIDER 1899200 M5 ROHS |
| 00643169588110 | MICRODEBRIDER 1899200RF M5 REFURB ROHS |
| 00643169492035 | MICRODEBRIDER 1899200RF M5 REFURB ROHS |
| 00643169448131 | MICRODEBRIDER 1899200 M5 ROHS |
| 00643169448124 | INSTRUMENT TRAY 1899076 M5 |
| 00643169448117 | INSTRUMENT TRAY 1898075 M4 |
| 20681490049140 | TUBING 1895522 5PK STRAIGHTSHOT TO XPS |
| 00763000172138 | INSTRUMENT TRAY 1899076 M5 |
Trademark Results [STRAIGHTSHOT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 STRAIGHTSHOT 85966970 not registered Dead/Abandoned |
North American Specialty Products LLC 2013-06-21 |
 STRAIGHTSHOT 85829013 4472379 Live/Registered |
NORTH AMERICAN SPECIALTY PRODUCTS LLC 2013-01-22 |
 STRAIGHTSHOT 78678959 3288807 Live/Registered |
NABORS DRILLING TECHNOLOGIES USA, INC. 2005-07-26 |
 STRAIGHTSHOT 75652661 not registered Dead/Abandoned |
Heartport, Inc 1999-03-03 |
 STRAIGHTSHOT 75154044 2114841 Live/Registered |
Medtronic Xomed, Inc. 1996-08-19 |
 STRAIGHTSHOT 73358781 not registered Dead/Abandoned |
JODY MELTEBEKE, SCOTT STAFFORD, MARKSTAFFORD, MICHAEL MORGAN, AND LAURASYLVESTER 1982-04-08 |
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