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 |
10840642170887 - Exceed™ Biplanar Expandable Interbody System | 2023-12-19 22 mm (L) x 10 mm (W) x 9 mm (H), Lordotic 0° |
10840642170894 - Exceed™ Biplanar Expandable Interbody System | 2023-12-19 22 mm (L) x 10 mm (W) x 10 mm (H), Lordotic 0° |
10840642170900 - Exceed™ Biplanar Expandable Interbody System | 2023-12-19 22 mm (L) x 10 mm (W) x 11 mm (H), Lordotic 0° |
10840642170917 - Exceed™ Biplanar Expandable Interbody System | 2023-12-19 22 mm (L) x 10 mm (W) x 12 mm (H), Lordotic 0° |
10840642170924 - Exceed™ Biplanar Expandable Interbody System | 2023-12-19 22 mm (L) x 10 mm (W) x 13 mm (H), Lordotic 0° |
10840642170931 - Exceed™ Biplanar Expandable Interbody System | 2023-12-19 22 mm (L) x 10 mm (W) x 14 mm (H), Lordotic 0° |
10840642170948 - Exceed™ Biplanar Expandable Interbody System | 2023-12-19 25 mm (L) x 10 mm (W) x 9 mm (H), Lordotic 0° |
10840642170955 - Exceed™ Biplanar Expandable Interbody System | 2023-12-19 25 mm (L) x 10 mm (W) x 10 mm (H), Lordotic 0° |