Treace Percuplasty

FDA UDI

Class I (US FDA UDI)

by Aseptico, Inc.

Identity

Trade Name: Treace Percuplasty FDA UDI
Generic Name: Bone/joint surgical power tool motor, electric FDA UDI
Device Name: Surgical Motor System W/ VARIABLE-SPEED FOOTSWITCH FDA UDI
Model / Reference: AEU-1070TRE-70V FDA UDI
Description: Surgical Motor System W/ VARIABLE-SPEED FOOTSWITCH FDA UDI

Identifiers

Primary DI / UDI-DI: 10817417020319 FDA UDI
FDA Product Code: GEY FDA UDI
GMDN Term: Bone/joint surgical power tool motor, electric FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4820 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone/joint surgical power tool motor, electric

Treace Percuplasty by Aseptico, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Midas Rex® — Medtronic Powered Surgical Solutions · Class II
Brasseler EZX — IMEDICOM CO., LTD. · Class I
Brasseler EZX — IMEDICOM CO., LTD. · Class I
EZX — IMEDICOM CO., LTD. · 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: Aseptico, Inc.

Sources (1)

FDA UDI 86281b47-b85a-40ac-90e3-36aaa321a2c5 36 fields · synced Jun 8, 2026