AccessGUDID - DEVICE: PROPEL Mini Sinus Implant with Straight Delivery System (M927600440)

GUDID

Device Identifier (DI) Information

Brand Name: PROPEL Mini Sinus Implant with Straight Delivery System
Version or Model: 60044
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Intersect Ent, Inc.

Primary DI Number: M927600440
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 876715355 *Terms of Use

Device Description: PROPEL Mini Sinus Implant with Straight Delivery System (SDS)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
48121	Paranasal sinus spacer	A sterile device temporarily implanted 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OWO	Drug-Eluting Sinus Stent

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P100044	046

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Stent Length: 18 Millimeter
Maximum Stent Diameter: 42.5 Millimeter

Device Record Status

Public Device Record Key: 34a8a7ae-30f8-4bbf-badd-3ccdfc9bd884
Public Version Date: May 17, 2022
Public Version Number: 3
DI Record Publish Date: October 26, 2020