Identity
- Trade Name
- FASSIER-DUVAL TELESCOPIC IM SYSTEM FDA UDI
- Generic Name
- Tibia intramedullary nail FDA UDI
- Device Name
- FULL IMPLANTS STERILIZATION CASE FDA UDI
- Model / Reference
- FD-IMPLSET FDA UDI
- Description
- FULL IMPLANTS STERILIZATION CASE FDA UDI
Identifiers
- Catalog Number
- FD-IMPLSET FDA UDI
- Primary DI / UDI-DI
- 07540194006073 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Tibia 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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Femur intramedullary nailTibia intramedullary nailHumerus intramedullary nail
Fassier-Duval Telescopic Im System by Orthopediatrics Canada ULC — 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
K020885 also covers:
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
K041393 also covers:
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
- FASSIER-DUVAL TELESCOPIC IM SYSTEM — Orthopediatrics Canada ULC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Orthopediatrics Canada ULC
Sources (1)
- FDA UDI 95e6abcb-8f9d-4677-bc1f-78eb2d881c5d 37 fields · synced May 30, 2026