Primary Device ID | B528100118031022150 |
NIH Device Record Key | d90ddec7-5283-4f1c-8fc9-272cdadb2106 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EPIPHANY |
Version Model Number | 1 |
Catalog Number | 1001-1803 1022-15 |
Company DUNS | 071012634 |
Company Name | PANTHEON SPINAL, 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 |
Phone | 5122154888 |
INFO@PANTHEON-SPINAL.COM | |
Phone | 5122154888 |
INFO@PANTHEON-SPINAL.COM |
Angle | 15 degree |
Angle | 15 degree |
Angle | 15 degree |
Angle | 15 degree |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B528100118031022150 [Primary] |
MAX | Intervertebral Fusion Device With Bone Graft, Lumbar |
Steralize Prior To Use | true |
Device Is Sterile | false |
[B528100118031022150]
Moist Heat or Steam Sterilization
[B528100118031022150]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 5 |
Public Version Date | 2019-12-09 |
Device Publish Date | 2018-01-21 |
B582PSE55120 | EPIPHANY 5/1 PEEK |
B528PSL60140 | EPIPHANY PEEK IMPLANT |
B528PSL60120 | EPIPHANY PEEK IMPLANT |
B528PSL60100 | EPIPHANY PEEK IMPLANT |
B528PSL60080 | EPIPHANY PEEK IMPLANT |
B528PSL55140 | EPIPHANY PEEK IMPLANT |
B528PSL55120 | EPIPHANY PEEK IMPLANT |
B528PSL55100 | EPIPHANY PEEK IMPLANT |
B528PSL55080 | EPIPHANY PEEK IMPLANT |
B528PSL50140 | EPIPHANY PEEK IMPLANT |
B528PSL50120 | EPIPHANY PEEK IMPLANT |
B528PSL50100 | EPIPHANY PEEK IMPLANT |
B528PSL50080 | EPIPHANY PEEK IMPLANT |
B528PSL45140 | EPIPHANY PEEK IMPLANT |
B528PSL45120 | EPIPHANY PEEK IMPLANT |
B528PSL45100 | EPIPHANY PEEK IMPLANT |
B528PSL45080 | EPIPHANY PEEK IMPLANT |
B528PSL40140 | EPIPHANY PEEK IMPLANT |
B528PSL40120 | EPIPHANY PEEK IMPLANT |
B528PSL40100 | EPIPHANY PEEK IMPLANT |
B528PSL40080 | EPIPHANY PEEK IMPLANT |
B528PSE60140 | EPIPHANY 5/1 PEEK |
B528PSE60120 | EPIPHANY 5/1 PEEK |
B528PSE60100 | EPIPHANY 5/1 PEEK |
B528PSE60080 | EPIPHANY 5/1 PEEK |
B528PSE55140 | EPIPHANY 5/1 PEEK |
B528PSE55100 | EPIPHANY 5/1 PEEK |
B528PSE55080 | EPIPHANY 5/1 PEEK |
B528PSE50140 | EPIPHANY 5/1 PEEK |
B528PSE50120 | EPIPHANY 5/1 PEEK |
B528PSE50100 | EPIPHANY 5/1 PEEK |
B528PSE50080 | EPIPHANY 5/1 PEEK |
B528PSE45140 | EPIPHANY 5/1 PEEK |
B528PSE45120 | EPIPHANY 5/1 PEEK |
B528PSE45100 | EPIPHANY 5/1 PEEK |
B528PSE45080 | EPIPHANY 5/1 PEEK |
B528PSE40140 | EPIPHANY 5/1 PEEK |
B528PSE40120 | EPIPHANY 5/1 PEEK |
B528PSE40100 | Epiphany 5/1 PEEK |
B528PSE40080 | Epiphany 5/1 PEEK |
B5285714460 | T-Handle |
B5285714400 | Access Case |
B52810330 | Implant Case |
B52810320 | Disc Prep Case |
B52810310 | Access Case |
B528102814000 | 14MM ANGLED TRIAL |
B528102812000 | 12MM ANGLED TRIAL |
B528102810000 | 10MM ANGLED TRIAL |
B528102808000 | 8MM ANGLED TRIAL |
B528102806000 | 6MM ANGLED TRIAL |