Entellus Medical FocESS Sinuscope ES-0

GUDID 00857326005598

Zero Degree 3mm FocESS Sinuscope, Autoclavable

ENTELLUS MEDICAL, INC.

Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope Rigid optical sinoscope
Primary Device ID00857326005598
NIH Device Record Keya928c914-9f89-4f66-9a34-a6c07f3c00fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEntellus Medical FocESS Sinuscope
Version Model NumberES-0
Catalog NumberES-0
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter
Angle0 degree
Outer Diameter3 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Avoid Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid Direct Sunlight
Special Storage Condition, SpecifyBetween 0 and 0 *Avoid Direct Sunlight

Device Identifiers

Device Issuing AgencyDevice ID
GS100857326005598 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOBNasopharyngoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

[00857326005598]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-11-30

On-Brand Devices [Entellus Medical FocESS Sinuscope]

00857326005628Seventy Degree 3mm FocESS Sinuscope, Autoclavable
00857326005611Forty-Five Degree 3mm FocESS Sinuscope, Autoclavable
00857326005604Thirty Degree 3mm FocESS Sinuscope, Autoclavable
00857326005598Zero Degree 3mm FocESS Sinuscope, Autoclavable
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