Shaver System Cleaning Brush

GUDID 00850002250190

The Shaver System Cleaning Brush is an accessory to the Shaver System. The Shaver System shapes bone and resects soft and hard tissues in the areas of otorhinolaryngology.

ENTELLUS MEDICAL, INC.

Surgical instrument/endoscope cleaning brush/tool, reusable
Primary Device ID00850002250190
NIH Device Record Keyad9f4686-e991-454d-852c-01e479926a54
Commercial Distribution StatusIn Commercial Distribution
Brand NameShaver System Cleaning Brush
Version Model NumberSSA-108
Company DUNS017283879
Company NameENTELLUS MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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
GS100850002250190 [Primary]

FDA Product Code

ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-05
Device Publish Date2020-09-25

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