Identity
- Trade Name
- CALCANAIL® FDA UDI
- Generic Name
- Arthrodesis intramedullary nail, non-distracting FDA UDI
- Model / Reference
- 268313-Calcanail nail Ø10 Lg55mm + Cap_Fracture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03661489683138 FDA UDI
- FDA Product Code
- HSB FDA UDI
- GMDN Term
- Arthrodesis intramedullary nail, non-distracting 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Category: Arthrodesis intramedullary nail, non-distracting
Calcanail® by Fournitures Hospitalieres Industrie — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthrodesis intramedullary nail, non-distracting.
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- AUTOBAHN — GLOBUS MEDICAL, INC. · Class II
- Reconstruction nail; long, 12×320 mm, 135°, left, cannulated — MEDIN, a.s. · Class IIb
- ZİMED MEDİKAL SANAYİ VE TİCARET LİMİTED ŞİRKETİ — Zimed Medikal Sanayi ve Ticaret Limited Şirketi · Class IIb
- INTREX — Bonetech Medisys Pvt. Ltd. · Class IIb
- Locking Screw — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- Ankle Compression Nailing System — Orthofix, Inc. · Class II
- Femoral Nail — WUHAN MINDRAY SCIENTIFIC CO., LTD. · Class IIb
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
- Fournitures Hospitalieres Industrie
Sources (1)
- FDA UDI f9e66b6f-8da7-4e92-b4d7-addfe6ee04dd 32 fields · synced Jun 8, 2026