Primary Device ID | 00643169864429 |
NIH Device Record Key | 689f482c-94bb-42c3-a5ca-57f8bc2e5c8a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HYDROCLEANSE™ |
Version Model Number | 1960100 |
Company DUNS | 835465063 |
Company Name | MEDTRONIC XOMED, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | 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 |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169864429 [Primary] |
KAR | IRRIGATOR, SINUS |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2018-09-10 |
Device Publish Date | 2018-08-09 |
00763000033385 - HA/C Polycel® Brackmann Total | 2024-05-20 PROSTHESIS 1112303 BRACKMANN H/AC TOTAL |
00763000034832 - Sheehy HA/C Polycel® P.O.P. | 2024-05-20 PROSTHESIS 1112362 SHEEHY POP H/A POLYCL |
00763000034849 - Sheehy HA/C Polycel® T.O.P. | 2024-05-20 PROSTHESIS 1112363 SHEEHY TOP H/A POLYCL |
00763000036591 - Big Easy® Piston | 2024-05-20 PROSTHESIS 1156611 PLAT/TI .5X4.5MM LFT |
00763000036607 - Big Easy® Piston | 2024-05-20 PROSTHESIS 1156612 PLAT/TI .5X4.75MM LFT |
00763000036614 - Big Easy® Piston | 2024-05-20 PROSTHESIS 1156613 PLAT/TI .5X5MM LEFT |
00763000036621 - Big Easy® Piston | 2024-05-20 PROSTHESIS 1156621 PLAT/TI .5X4.5MM RT |
00763000036638 - Big Easy® Piston | 2024-05-20 PROSTHESIS 1156622 PLAT/TI .5X4.75M RT |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HYDROCLEANSE 98000643 not registered Live/Pending |
Cater, Jim 2023-05-17 |
HYDROCLEANSE 98000643 not registered Live/Pending |
Cater, James 2023-05-17 |
HYDROCLEANSE 87301157 5857865 Live/Registered |
Medtronic Xomed, Inc. 2017-01-13 |
HYDROCLEANSE 87155366 not registered Dead/Abandoned |
Medtronic Xomed, Inc. 2016-08-30 |
HYDROCLEANSE 86384676 not registered Dead/Abandoned |
Oculus Innovative Sciences, Inc. 2014-09-03 |