Ipp-On®

FDA UDI

Class I (US FDA UDI)

by Newdeal Sas

Identity

Trade Name: IPP-ON® FDA UDI
Generic Name: Manual surgical rotary handpiece, reusable FDA UDI
Device Name: The distal PIP Fusion hand drill is used to prepare the distal phalanx and to define the size of the implant. This model is size 2. FDA UDI
Model / Reference: 239021ND FDA UDI
Description: The distal PIP Fusion hand drill is used to prepare the distal phalanx and to define the size of the implant. This model is size 2. FDA UDI

Identifiers

Primary DI / UDI-DI: 10381780045021 FDA UDI
FDA Product Code: HTO FDA UDI
GMDN Term: Manual surgical rotary handpiece, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Manual surgical rotary handpiece, reusable

Ipp-On® by Newdeal Sas — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Manual surgical rotary handpiece, reusable.

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GII — Medos International Sàrl · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
HNM Medical — HNM STAINLESS, LLC. · Class I
HALLMARK — Orthofix US LLC · Class I
CHESAPEAKE Stabilization System — K2M, INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Newdeal Sas

Sources (1)

FDA UDI 402826bb-ada2-48fa-a200-d0e1a9ed3e48 36 fields · synced May 30, 2026