AccessGUDID - DEVICE: Propel Mini (M927600110)

GUDID

Device Identifier (DI) Information

Brand Name: Propel Mini
Version or Model: 60011
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Intersect Ent, Inc.

Primary DI Number: M927600110
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

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	001

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: 2479a718-fca9-430d-aca3-2f3aab4f10f5
Public Version Date: May 17, 2022
Public Version Number: 6
DI Record Publish Date: July 29, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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