Propel Mini Straight Delivery System (SDS) Single Unit

Primary DI
M92710061
Brand
Propel Mini Straight Delivery System (SDS) Single Unit
Company
Intersect Ent, Inc.
Model
10061
Published
2019-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
OWODrug-Eluting Sinus Stent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OWODrug-Eluting Sinus StentUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P100044038

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P100044038PROPELIntersect Ent.2011-08-11OWO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M92710065PackageHIBCC5In Commercial Distribution
M92710061PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Paranasal sinus spacerA sterile device temporarily introduced into the sinus to maintain an opening and prevent obstruction. It is used for the local moistening of the sinuses through delivery of a selected fluid (e.g., saline or a drug) to treat sinusitis. It is typically designed as a microflow catheter with a micropore reservoir at the distal end which gradually releases the fluid. The implantation procedure is assisted through fluoroscopy or endoscopy. A disposable sinus spacer deployment device will typically be included.

Regulatory Flags#

DUNS number
876715355
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M927700110Propel700112014-07-29
M927500110Propel Contour500112017-02-27
M927600110Propel Mini600112014-07-29
M927600440PROPEL Mini Sinus Implant with Straight Delivery System600442020-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000710279PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
00763000710330PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
00763000710392PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
00763000710453PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
20763000710303PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
20763000710365PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
20763000710426PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
20763000710464PROPELMEDTRONIC XOMED, INC.OWO2023-07-08
M927600440PROPEL Mini Sinus Implant with Straight Delivery SystemIntersect Ent, Inc.OWO2020-10-26
M927500110Propel ContourIntersect Ent, Inc.OWO2017-02-27
M927700110PropelIntersect Ent, Inc.OWO2014-07-29
M927600110Propel MiniIntersect Ent, Inc.OWO2014-07-29