Identity
- Trade Name
- DINAMIC T HUMERUS FDA UDI
- Generic Name
- Humerus intramedullary nail FDA UDI
- Device Name
- Kit composed of: - Humeral nail ø7mm L240mm (1 pc); - Guide wire (3 pcs). Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI
- Model / Reference
- Long nail ø7mm L240mm, left FDA UDI
- Description
- Kit composed of: - Humeral nail ø7mm L240mm (1 pc); - Guide wire (3 pcs). Material of the nail: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI
Identifiers
- Catalog Number
- DT725240 FDA UDI
- Primary DI / UDI-DI
- 08052990970186 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 10 Millimeter FDA UDIOuter Diameter — 8 Millimeter FDA UDIOuter Diameter — 7 Millimeter FDA UDILength — 240 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:
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
- DINAMIC T HUMERUS — Citieffe
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 06e6d001-5d75-47ab-b4be-ea3b94910a79 38 fields · synced Jun 8, 2026