LASE Endoscopic Discectomy Set 1100-002

GUDID B06711000020

LASE Endoscopic Discectomy Set, with Tubing Set. For use with HO:YAG Lasers with a SMA 905 connector.

CLARUS MEDICAL, LLC

Lumbar decompression procedure kit
Primary Device IDB06711000020
NIH Device Record Key573bd0fa-0e11-438a-870e-631131674de9
Commercial Distribution StatusIn Commercial Distribution
Brand NameLASE Endoscopic Discectomy Set
Version Model Number1100-002
Catalog Number1100-002
Company DUNS010316284
Company NameCLARUS MEDICAL, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone763-525-8400
Emailadmin@clarus-medical.com
Phone763-525-8400
Emailadmin@clarus-medical.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius
Storage Environment TemperatureBetween -18 Degrees Celsius and 52 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB06711000020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

On-Brand Devices [LASE Endoscopic Discectomy Set]

B0671100010L0LASE Endoscopic Discectomy System (Long), with Tubing Set. For use with HO:YAG lasers with a Tr
B06711000100LASE Endoscopic Discectomy System, with Tubing Set. For use with HO:YAG lasers with a Trimedyne
B0671100002SHORT0LASE Endoscopic Discectomy Set (Short), with Tubing Set. For use with HO:YAG Lasers with a SMA
B0671100002S0LASE Endoscopic Discectomy Set (Short), with Tubing Set. For use with HO:YAG Lasers with a SMA
B06711000020LASE Endoscopic Discectomy Set, with Tubing Set. For use with HO:YAG Lasers with a SMA 905 conn

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