Dinamic T Humerus

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: DINAMIC T HUMERUS FDA UDI
Generic Name: Manual surgical rotary handpiece, reusable FDA UDI
Model / Reference: Quick-connect T handle FDA UDI

Identifiers

Catalog Number: DT070065 FDA UDI
Primary DI / UDI-DI: 08032909629831 FDA UDI
510(k) Number: K113387 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Manual surgical rotary handpiece, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 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

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

Dinamic T Humerus by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Manual surgical rotary handpiece, reusable.

RENOIR Posterior Cervico-Thoracic Fixation System — CTL Medical Corporation · Class I
MANUAL HANDPIECE DRIVER, FITS LATCH CONNECT 1:1 RATIO — W.H. Holden, Inc. · Class I
Invivo — Philips DS North America LLC · Class II
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

Cleared under the same submission

K113387 also covers:

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: Citieffe

Sources (1)

FDA UDI f433c25b-e31a-4564-83e8-6c07ae3a4265 36 fields · synced May 30, 2026