Propel

FDA UDI

Class II (US FDA UDI)

by Propel Orthodontics Llc

Identity

Trade Name: Propel FDA UDI
Generic Name: Surgical drill guide, single-use FDA UDI
Device Name: Assy. Packaged Disposable Drill Tip-Open FDA UDI
Model / Reference: ASM-20010-02 FDA UDI
Description: Assy. Packaged Disposable Drill Tip-Open FDA UDI

Identifiers

Catalog Number: ASM-20010-02 FDA UDI
Primary DI / UDI-DI: 00852673007059 FDA UDI
FDA Product Code: DZJ FDA UDI
GMDN Term: Surgical drill guide, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.4120 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

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

Sterilization Method

Radiation Sterilization FDA UDI

Category: Surgical drill guide, single-use

Propel by Propel Orthodontics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Propel Orthodontics Llc

Sources (1)

FDA UDI 58047bd3-632e-4fda-8ead-3e44044db7de 35 fields · synced Jun 8, 2026