Primary Device ID | B047CGRP1300 |
NIH Device Record Key | 1b680321-8c0b-4d67-95cd-b665423790ad |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SPINENET ACC ® |
Version Model Number | CGRP1300 |
Company DUNS | 792052321 |
Company Name | SPINENET, LLC |
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 | false |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B047CGRP1300 [Primary] |
ODP | Intervertebral Fusion Device With Bone Graft, Cervical |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B047CGRP1300]
Moist Heat or Steam Sterilization
[B047CGRP1300]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-10-10 |
B047CTRC1400 | SPINENET ACC ® -Transportation Case |
B047CL1012050 | 10mmx12mmx5mm |
B047CINS1100 | SpineNet ACC® Inserter Assembly-Instrument |
B047CGRP1300 | SPINENET ACC ® Graft Pusher-Instrument |
B047CGRB1200 | SPINENET ACC ® Graft Block-Instrument |