FDA UDI
In Commercial Distribution
🇺🇸 United States
PROPEL
DI: 00763000710392
·
Model: 50011-
·
MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- PROPEL
- Primary DI
- 00763000710392
- Version / Model
- 50011-
- Company Name
- MEDTRONIC XOMED, INC.
- Labeler DUNS
- 835465063
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-08
- Public Version
- 2
- Public Version Date
- 2024-03-05
- Public Version Status
- Update
- Public Device Record Key
- d3410adb-6849-4322-99ab-dbcc1d257a53
Device Description
IMPLANT 50011- PROPEL CONTOUR
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- Yes
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OWO | Drug-eluting sinus stent | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20763000710426 | GS1 | PK | 5 | In Commercial Distribution | |
| Primary | 00763000710392 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P100044 | 023 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius