Shaver System Irrigation Clips

GUDID 00850002250183

The Shaver System Irrigation Clips are an accessory to the Shaver System Irrigation Stand. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

Surgical irrigation tubing set, reusable
Primary Device ID00850002250183
NIH Device Record Key9f97ace4-d40d-4621-a3df-e083dfba85d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameShaver System Irrigation Clips
Version Model NumberSSA-106
Company DUNS017283879
Company NameENTELLUS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850002250183 [Primary]

FDA Product Code

GBXCatheter, Irrigation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-02
Device Publish Date2020-09-24

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