AccessGUDID - DEVICE: PROPEL (00763000710453)

GUDID

Device Identifier (DI) Information

Brand Name: PROPEL
Version or Model: 60044-
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC XOMED, INC.

Primary DI Number: 00763000710453
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835465063 *Terms of Use

Device Description: IMPLANT 60044- PROPEL MINI WITH 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):	No
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?
61370	Drug-eluting paranasal sinus stent	A bioabsorbable device with a drug coating intended to be implanted into a paranasal sinus (e.g., frontal, sphenoidal, ethmoidal, maxillary) to maintain sinus patency in the treatment of chronic sinusitis. The drug coating is intended to reduce inflammation and polyps to facilitate the separation of sinus mucosal tissues. The device is made of synthetic polymer(s) capable of being degraded and absorbed by body tissues, and is designed to allow for the slow release of the drug coating. It is endoscopically implanted via the nasal passageway; disposable devices associated with implantation may be included.	Active	true

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 669895b5-e3f6-4981-bde7-422698c776c2
Public Version Date: March 05, 2024
Public Version Number: 2
DI Record Publish Date: July 08, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20763000710464	5	00763000710453		In Commercial Distribution	PK

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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)633-8766
Email: Corporate.UDI@medtronic.com

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