Primary Device ID | 00643169868854 |
NIH Device Record Key | 8b416fd8-2b98-46a6-b239-c117566e2552 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Sophono™ |
Version Model Number | S1000-00 |
Company DUNS | 835465063 |
Company Name | MEDTRONIC XOMED, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Conditional |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
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 |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169868854 [Primary] |
LBX | PELVIMETER, INTERNAL |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2017-10-02 |
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 |
---|---|
![]() SOPHONO 85856537 4544562 Live/Registered |
Sophono, Inc. 2013-02-21 |