ISO GARD HEPA SMALL S STERILE (UDI 04026704348565)
Manufactured by Teleflex Medical Sdn. Bhd.
Device Regulatory Overview
The ISO GARD HEPA SMALL S STERILE (Model/Catalog Number: 28061) is a medical device manufactured by Teleflex Medical Sdn. Bhd.. This product is indexed under FDA Product Code / Category Classification R040101 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 28061
- Product Code / EMDN
- R040101
- Device Name
- ISO-GARD HEPA SMALL STRAIGHT STERIL
- Database Sync Date
- 2026-08-09 16:28:52
Full Regulatory Attributes
π Token Gated
{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of ISO GARD HEPA SMALL S STERILE?
The registered manufacturer of record for ISO GARD HEPA SMALL S STERILE is Teleflex Medical Sdn. Bhd..
What is the Primary UDI-DI identifier for ISO GARD HEPA SMALL S STERILE?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 04026704348565.
What classification code is assigned to this device?
This device is registered under product classification code R040101.
Similar Classification Devices (R040101)
Other Devices by Teleflex Medical Sdn. Bhd.
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