AccessGUDID - DEVICE: LASE Endoscopic Discectomy Set (B06711000020)

GUDID

Device Identifier (DI) Information

Brand Name: LASE Endoscopic Discectomy Set
Version or Model: 1100-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1100-002
Company Name: CLARUS MEDICAL, LLC

Primary DI Number: B06711000020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 010316284 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37890	Lumbar decompression procedure kit	A collection of sterile devices used to perform percutaneous, minimally-invasive lumbar decompression (MILD) for the treatment of various spine conditions, typically in conjunction with an endoscope. It typically includes trocars, cannulae (portals), a retractor, and other essential materials for the procedure; it may also include a disposable endoscope. It is used for image-guided tissue resection of the lumbar spine involving retraction, grasping, cutting, ablation, and coagulation of the spinal tissues. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered Laser Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922881	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -18 and 52 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 573bd0fa-0e11-438a-870e-631131674de9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016