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.

Nasal knife Nasal knife Nasal knife Nasal knife Nasal knife Nasal knife Nasal knife Nasal knife Nasal knife Nasal knife Nasal knife Nasal knife Nasal knife Nasal knife
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]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]
GS100857326005451 [Primary]

FDA Product Code

KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
KTGKnife, Ent
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


Device Entry Metadata

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

Devices Manufactured by ENTELLUS MEDICAL, INC.

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00857326005475 - MiniFESS Blakesley Forceps 45°2020-09-18 he MiniFESS Blakesley Forceps is a reusable device used to grasp, manipulate or extract tissue in the nasal or sinus cavity.
00857326005482 - MiniFESS Blakesley Forceps 90°2020-09-18 he MiniFESS Blakesley Forceps is a reusable device used to grasp, manipulate or extract tissue in the nasal or sinus cavity.
10857326005533 - XeroGel Nasal/Epistaxis 2 Pack2020-09-18 XeroGel Nasal/Epistaxis Pack is a sterile, single use, co-polymer of polyethylene glycol (PEG) and chitosan provided as a dry pa
10857326005540 - XeroGel Nasal/Epistaxis 8 Pack2020-09-18 XeroGel Nasal/Epistaxis Pack is a sterile, single use, co-polymer of polyethylene glycol (PEG) and chitosan provided as a dry pa
00857326005185 - MiniFess Maxilary Seeker 120°2020-09-16 The MiniFESS Maxillary Seeker is a reusable, stainless steel surgical instrument used to probe within the sinuses using a trans-
00857326005192 - MiniFess Maxilary Seeker 135°2020-09-16 The MiniFESS Maxillary Seeker is a reusable, stainless steel surgical instrument used to probe within the sinuses using a trans-
00857326005208 - MiniFESS Sphenoid Seeker/Freer2020-09-16 The MiniFESS Sphenoid Seeker/Freer is a reusable, stainless steel surgical instrument used to probe and create space within the

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