STRAIGHTSHOT®
GUDID 00643169588127
MICRODEBRIDER 1899200 M5 ROHS
MEDTRONIC XOMED, INC.
Multi-purpose surgical power tool system, line-powered| 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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