Primary Device ID | 00643169715127 |
NIH Device Record Key | 2d2191c4-3d6f-43af-b16f-597d92e5f64a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Medtronic HV-R® Fenestrated Screw Cement |
Version Model Number | 7480724T |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169715127 [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 | 2016-04-09 |
00763000855017 - n/a | 2025-06-06 INSTRUMENT 6248186 11X18X16 TRIAL |
00763000855215 - n/a | 2025-06-06 INSTRUMENT 6248864 8X16X14 TRIAL |
00763000889159 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3120315 4.0 X 15 SELF TAP VAR |
00763000889166 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3120314 4.0 X 14 SELF TAP VAR |
00763000889173 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3120313 4.0 X 13 SELF TAP VAR |
00763000889227 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3125313 4.5 X 13 SELF TAP VAR |
00763000889319 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3120214 4.0 X 14 SELF TAP FIX |
00763000889425 - ATLANTIS® Anterior Cervical Plate System | 2025-06-06 SCREW 3120514 4.0 X 14 SELF DRILL VAR |