Identity
- Trade Name
- Propel Mini FDA UDI
- Generic Name
- Paranasal sinus spacer FDA UDI
- Device Name
- PROPEL Mini Sinus Implant FDA UDI
- Model / Reference
- 60011 FDA UDI
- Description
- PROPEL Mini Sinus Implant FDA UDI
Identifiers
- Primary DI / UDI-DI
- M927600110 FDA UDI
- PMA Number
- P100044 FDA UDI
- FDA Product Code
- OWO FDA UDI
- GMDN Term
- Paranasal sinus spacer FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Stent Length — 18 Millimeter FDA UDIMaximum Stent Diameter — 42.5 Millimeter FDA UDI
Category: Paranasal sinus spacer
Propel Mini by Intersect Ent. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Paranasal sinus spacer.
- Salman FES Stent — Boston Medical Products, Inc. · Class I
- Salman FES Stent — Boston Medical Products, Inc. · Class I
- Propel Mini Straight Delivery System (SDS) Single Unit — Intersect Ent. · Class III
- Propel — Intersect Ent. · Class III
- PROPEL Mini Sinus Implant with Straight Delivery System — Intersect Ent. · Class III
- Propel Contour — Intersect Ent. · Class III
Cleared under the same submission
P100044 also covers:
- PROPEL Mini Sinus Implant with Straight Delivery System — Intersect Ent.
- Propel — Intersect Ent.
- Propel Contour — Intersect Ent.
- Propel Mini Straight Delivery System (SDS) Single Unit — Intersect Ent.
- PROPEL — MEDTRONIC XOMED, INC.
- PROPEL — MEDTRONIC XOMED, INC.
- PROPEL — MEDTRONIC XOMED, INC.
- PROPEL — MEDTRONIC XOMED, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Intersect Ent.
Sources (1)
- FDA UDI 2479a718-fca9-430d-aca3-2f3aab4f10f5 35 fields · synced Jun 8, 2026