DEVICE: LASE Endoscopic Discectomy Set (B06711000020)

Device Identifier (DI) Information

LASE Endoscopic Discectomy Set
1100-002
In Commercial Distribution
1100-002
CLARUS MEDICAL, LLC
B06711000020
HIBCC

1
010316284 *Terms of Use
LASE Endoscopic Discectomy Set, with Tubing Set. For use with HO:YAG Lasers with a SMA 905 connector.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

[?]
Product Code Product Code Name
GEX Powered Laser Surgical Instrument
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -18 and 52 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

573bd0fa-0e11-438a-870e-631131674de9
March 29, 2018
2
September 20, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
763-525-8400
admin@clarus-medical.com
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