PROPEL Mini Sinus Implant with Straight Delivery System

FDA UDI

Class III (US FDA UDI)

by Intersect Ent.

Identity

Trade Name: PROPEL Mini Sinus Implant with Straight Delivery System FDA UDI
Generic Name: Paranasal sinus spacer FDA UDI
Device Name: PROPEL Mini Sinus Implant with Straight Delivery System (SDS) FDA UDI
Model / Reference: 60044 FDA UDI
Description: PROPEL Mini Sinus Implant with Straight Delivery System (SDS) FDA UDI

Identifiers

Primary DI / UDI-DI: M927600440 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

Yes

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Stent Length — 18 Millimeter FDA UDI
Maximum Stent Diameter — 42.5 Millimeter FDA UDI

Category: Paranasal sinus spacer

PROPEL Mini Sinus Implant with Straight Delivery System 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 — Intersect Ent. · Class III
Propel Mini Straight Delivery System (SDS) Single Unit — Intersect Ent. · Class III
Propel — Intersect Ent. · Class III
Propel Contour — Intersect Ent. · Class III

Cleared under the same submission

P100044 also covers:

Propel — Intersect Ent.
Propel Contour — Intersect Ent.
Propel Mini — 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 34a8a7ae-30f8-4bbf-badd-3ccdfc9bd884 35 fields · synced Jun 1, 2026