AESCULAP (UDI FA005R)
Manufactured by Aesculap AG
Device Regulatory Overview
The AESCULAP (Model/Catalog Number: FA005R) is a medical device manufactured by Aesculap AG. This product is indexed under FDA Product Code / Category Classification KCF within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R....
AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R....
Technical Specifications
- Model Number
- FA005R
- Product Code / EMDN
- KCF
- Device Name
- TROUSSEAU Tracheal Dilator, 4 3/4", (120 mm), non-sterile, reusable
- Database Sync Date
- 2026-08-09 09:37:58
Full Regulatory Attributes
🔒 Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
Unlock Compliance Data & Serialization Specs
Access raw JSON payloads, UDI-DI packaging hierarchies, and Notified Body IDs.
Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of AESCULAP?
The registered manufacturer of record for AESCULAP is Aesculap AG.
What is the Primary UDI-DI identifier for AESCULAP?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is FA005R.
What classification code is assigned to this device?
This device is registered under product classification code KCF.
Similar Classification Devices (KCF)
Other Devices by Aesculap AG
Programmatic Export
Export this master device record as standardized JSON or CSV for compliance audits.
JSON API Endpoint