Primary Device ID | B06711000020 |
NIH Device Record Key | 573bd0fa-0e11-438a-870e-631131674de9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | LASE Endoscopic Discectomy Set |
Version Model Number | 1100-002 |
Catalog Number | 1100-002 |
Company DUNS | 010316284 |
Company Name | CLARUS MEDICAL, 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 | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | false |
Serial Number | true |
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 | 763-525-8400 |
admin@clarus-medical.com | |
Phone | 763-525-8400 |
admin@clarus-medical.com |
Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
Storage Environment Temperature | Between -18 Degrees Celsius and 52 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B06711000020 [Primary] |
GEX | Powered Laser Surgical Instrument |
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 | 2016-09-20 |
B0671100010L0 | LASE Endoscopic Discectomy System (Long), with Tubing Set. For use with HO:YAG lasers with a Tr |
B06711000100 | LASE Endoscopic Discectomy System, with Tubing Set. For use with HO:YAG lasers with a Trimedyne |
B0671100002SHORT0 | LASE Endoscopic Discectomy Set (Short), with Tubing Set. For use with HO:YAG Lasers with a SMA |
B0671100002S0 | LASE Endoscopic Discectomy Set (Short), with Tubing Set. For use with HO:YAG Lasers with a SMA |
B06711000020 | LASE Endoscopic Discectomy Set, with Tubing Set. For use with HO:YAG Lasers with a SMA 905 conn |