Primary Device ID | 00643169603486 |
NIH Device Record Key | 9354d12a-576d-4b6a-9b98-65d1818a6194 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | CD HORIZON ESSENTIALS™ Spinal System |
Version Model Number | E7540MASKIT |
Company DUNS | 830350380 |
Company Name | MEDTRONIC SOFAMOR DANEK, 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 | 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 |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Length | 40 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169603486 [Primary] |
MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
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 | 2015-12-17 |
00643169603493 | SCREW KIT E7545MASKIT ESSENCE MAS 7.5X45 |
00643169603486 | SCREW KIT E7540MASKIT ESSENCE MAS 7.5X40 |
00643169603455 | SCREW KIT E6550MASKIT ESSENCE MAS 6.5X50 |
00643169603448 | SCREW KIT E6545MASKIT ESSENCE MAS 6.5X45 |
00643169603431 | SCREW KIT E6540MASKIT ESSENCE MAS 6.5X40 |
00643169603424 | SCREW KIT E6535MASKIT ESSENCE MAS 6.5X35 |
00643169603387 | SCREW KIT E5540MASKIT ESSENCE MAS 5.5X40 |
00643169595132 | TRAY 7377004 SDS TL INTERBODY INS |
00643169595125 | TRAY 7377003 SDS TL DISC PREP INS |
00643169595118 | TRAY 7377002 SDS TL FIXATION INS 2 OF 2 |
00643169595101 | TRAY 7377001 SDS TL FIXATION INS 1 OF 2 |
00643169429062 | SCRW 45340006540 ESSENCE STRLEMAS6.5X40 |
00643169428959 | SCRW 45340007545 ESSENCE STRLEMAS7.5X45 |
00643169428928 | SET SCRW 4530020 ESSENCE STRL BREAK-OFF |
20643169490707 | ROD 5570ROD2PER PRE-BENT 5.5X70 TI STER |
20643169490691 | ROD 5560ROD2PER PRE-BENT 5.5X60 TI STER |
20643169490684 | ROD 5550ROD2PER PRE-BENT 5.5X50 TI STER |
20643169490677 | ROD 5540ROD2PER PRE-BENT 5.5X40 TI STER |
20643169490660 | ROD 5535ROD2PER PRE-BENT 5.5X35 TI STER |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() CD HORIZON ESSENTIALS 86702183 5023922 Live/Registered |
Warsaw Orthopedic, Inc. 2015-07-23 |