PowerForma®
GUDID 00681490073233
TUBING 3318501 POWERFORMA IRRIGATION
MEDTRONIC XOMED, INC.
Surgical irrigation tubing set, single-use| Primary Device ID | 00681490073233 |
| NIH Device Record Key | baed3ddb-92d9-4343-927e-15f4440d2806 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PowerForma® |
| Version Model Number | 3318501 |
| 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 | true |
| Serial Number | false |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490073233 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K791407
FDA Product Code
| ERL | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
[00681490073233]
Ethylene Oxide;Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-04-23 |
| Device Publish Date | 2016-04-23 |
On-Brand Devices [PowerForma®]
| 00681490073233 | TUBING 3318501 POWERFORMA IRRIGATION |
| 00681490051569 | ADAPTER 1994025 POWERFORMA HANDPIECE |
| 20681490049133 | TUBING 1895520 5PK PWRFORMA TO XPS IRRIG |
Trademark Results [PowerForma]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 POWERFORMA 75124112 2090158 Dead/Cancelled |
MEDTRONIC XOMED, INC. 1996-06-24 |
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