PROPEL Mini Sinus Implant with Straight Delivery System

GUDID M927600440

Intersect Ent, Inc.

Paranasal sinus spacer
Primary Device IDM927600440
NIH Device Record Key34a8a7ae-30f8-4bbf-badd-3ccdfc9bd884
Commercial Distribution StatusIn Commercial Distribution
Brand NamePROPEL Mini Sinus Implant with Straight Delivery System
Version Model Number60044
Company DUNS876715355
Company NameIntersect Ent, 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 Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Stent Length18 Millimeter
Maximum Stent Diameter42.5 Millimeter
Stent Length18 Millimeter
Maximum Stent Diameter42.5 Millimeter
Stent Length18 Millimeter
Maximum Stent Diameter42.5 Millimeter
Stent Length18 Millimeter
Maximum Stent Diameter42.5 Millimeter
Stent Length18 Millimeter
Maximum Stent Diameter42.5 Millimeter
Stent Length18 Millimeter
Maximum Stent Diameter42.5 Millimeter
Stent Length18 Millimeter
Maximum Stent Diameter42.5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM927600440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OWODrug-Eluting Sinus Stent

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-03-17
Device Publish Date2020-10-26

Devices Manufactured by Intersect Ent, Inc.

M927700110 - Propel2022-03-17
M927500110 - Propel Contour2022-03-17
M927600110 - Propel Mini2022-03-17
M927600440 - PROPEL Mini Sinus Implant with Straight Delivery System2022-03-17
M927600440 - PROPEL Mini Sinus Implant with Straight Delivery System2022-03-17

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