Dinamic T Humerus

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name: DINAMIC T HUMERUS FDA UDI
Generic Name: Humerus intramedullary nail FDA UDI
Device Name: Kit composed of: - Humeral nail ø7mm L300mm (1 pc); - Guide wire (3 pcs). Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI
Model / Reference: Long nail ø7mm L300mm, right FDA UDI
Description: Kit composed of: - Humeral nail ø7mm L300mm (1 pc); - Guide wire (3 pcs). Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI

Identifiers

Catalog Number: DT720300 FDA UDI
Primary DI / UDI-DI: 08052990970148 FDA UDI
510(k) Number: K113387 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Humerus intramedullary nail 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

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

Dimensions & Sizes

Size: Outer Diameter — 10 Millimeter FDA UDI
Outer Diameter — 8 Millimeter FDA UDI
Outer Diameter — 7 Millimeter FDA UDI
Length — 300 Millimeter FDA UDI

Category: Humerus intramedullary nail

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

Similar devices

Also classified as Humerus intramedullary nail.

TRIGEN — Smith & Nephew, Inc. · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
M/DN® — Zimmer, Inc. · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
TELEGRAPH® EVOLUTION Humeral Nailing System — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
MULTILOC — Synthes · Class II
TELEGRAPH® — FOURNITURES HOSPITALIERES INDUSTRIE · Class II
TRIGEN — Smith & Nephew, Inc. · Class II

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 d6e45829-2af4-455a-b746-b5088c987e67 38 fields · synced Jun 1, 2026