Primary Device ID | 10840642106855 |
NIH Device Record Key | 92d9b7b4-c0a7-44a6-911a-da85fd161368 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Velocity® Expandable Interbody System |
Version Model Number | 11-2364 |
Catalog Number | 11-2364 |
Company DUNS | 067789763 |
Company Name | Spine Wave, 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 | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 203-944-9494 |
GUDID@spinewave.com |
Height | 8 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 10840642106855 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2018-08-31 |
10840642119527 - Proficient™ Posterior Cervical Spine System | 2024-09-11 Screw, 4.2 mm X 50 mm |
10840642119534 - Proficient™ Posterior Cervical Spine System | 2024-09-11 Cannulated Screw, 3.8 mm X 08 mm |
10840642119541 - Proficient™ Posterior Cervical Spine System | 2024-09-11 Cannulated Screw, 3.8 mm X 10 mm |
10840642119558 - Proficient™ Posterior Cervical Spine System | 2024-09-11 Cannulated Screw, 3.8 mm X 12 mm |
10840642119565 - Proficient™ Posterior Cervical Spine System | 2024-09-11 Cannulated Screw, 3.8 mm X 14 mm |
10840642119572 - Proficient™ Posterior Cervical Spine System | 2024-09-11 Cannulated Screw, 3.8 mm X 16 mm |
10840642119589 - Proficient™ Posterior Cervical Spine System | 2024-09-11 Cannulated Screw, 3.8 mm X 18 mm |
10840642119596 - Proficient™ Posterior Cervical Spine System | 2024-09-11 Cannulated Screw, 3.8 mm X 20 mm |