MiniFESS Sphenoid Seeker/Freer

GUDID 00857326005208

The MiniFESS Sphenoid Seeker/Freer is a reusable, stainless steel surgical instrument used to probe and create space within the sinuses using a trans-nasal approach.

ENTELLUS MEDICAL, INC.

Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe Paranasal sinus probe
Primary Device ID00857326005208
NIH Device Record Key7cdda0a9-d984-4a2d-8adb-343e30e5ee69
Commercial Distribution StatusIn Commercial Distribution
Brand NameMiniFESS Sphenoid Seeker/Freer
Version Model NumberFS-100
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
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]
GS100857326005208 [Primary]

FDA Product Code

LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical
LRCInstrument, Ent Manual Surgical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

Moist Heat or Steam Sterilization


[00857326005208]

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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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/Freer2020-09-16The MiniFESS Sphenoid Seeker/Freer is a reusable, stainless steel surgical instrument used to probe and create space within the sinuses using a trans-nasal approach.
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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