MiniFESS Sickle Knife

GUDID 00857326005451

The MiniFESS Sickle Knife is a reusable device used to cut tissue in the nasal or sinus cavity.

ENTELLUS MEDICAL, INC.

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Primary Device ID00857326005451
NIH Device Record Keye3b867bf-bdf3-460a-828c-49e2114ca7d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniFESS Sickle Knife
Version Model NumberCS-105
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
GS100857326005451 [Primary]

FDA Product Code

KTGKnife, Ent

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


[00857326005451]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-16
Device Publish Date2020-09-08

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