Indigo™
GUDID 00643169882621
DRILL 1845000 INDIGO HIGH SPD OTOL ROHS
MEDTRONIC XOMED, INC.
Multi-purpose surgical power tool system, line-powered| Primary Device ID | 00643169882621 |
| NIH Device Record Key | 593f7fc6-1055-433a-959e-14cca4029655 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Indigo™ |
| Version Model Number | 1845000 |
| 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
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 33 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169882621 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081475
FDA Product Code
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
[00643169882621]
Moist Heat or Steam Sterilization;Ethylene Oxide
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2018-05-31 |
On-Brand Devices [Indigo™]
| 00613994933713 | DRILL 1845000 INDIGO HIGH SPD OTOL ROHS |
| 00613994933706 | ATTACHMENT 1845010 INDIGO OTOL STRAIGHT |
| 00613994933690 | ATTACHMENT 1845020 INDIGO OTOL ANGLED |
| 20613994933687 | TUBING 1845030 INDIGO 5PK |
| 00613994933676 | INSTRUMENT TRAY 1845040 INDIGO |
| 00643169882621 | DRILL 1845000 INDIGO HIGH SPD OTOL ROHS |
| 00643169789609 | INSTRUMENT TRAY 1845040 INDIGO |
| 00643169591202 | BUR 31310584 INDIGO RND STEEL CUT 0.5MM |
| 00643169591196 | BUR 31311084 INDIGO RND STEEL CUT 1.0MM |
| 00643169579309 | BUR 31313079 INDIGO RND STEEL CUT 3.0MM |
| 00643169579262 | BUR 31311583 INDIGO RND STEEL CUT 1.5MM |
| 00643169579255 | BUR 31312080 INDIGO RND STEEL CUT 2.0MM |
| 00643169579248 | BUR 31312579 INDIGO RND STEEL CUT 2.5MM |
| 00763000172091 | INSTRUMENT TRAY 1845040 INDIGO |
Trademark Results [Indigo]
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