gudid
Primary ID: MH-246R
BALLOON SHEATH (UDI MH-246R)
Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for BALLOON SHEATH - Primary ID MH-246R
Device Regulatory Overview
The BALLOON SHEATH (Model/Catalog Number: MH-246R) is a medical device manufactured by OLYMPUS MEDICAL SYSTEMS CORP.. This product is indexed under FDA Product Code / Category Classification FED within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- MH-246R
- Product Code / EMDN
- FED
- Device Name
- This model includes one of connector section and five of insertion sections. The connector section is reusable and requires autoclave sterilization prior to use. The insertion section is single-use and packaged as sterile. Please refer to the instruction manual for details.
- Database Sync Date
- 2026-08-09 09:46:01
Full Regulatory Attributes
🔒 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 BALLOON SHEATH?
The registered manufacturer of record for BALLOON SHEATH is OLYMPUS MEDICAL SYSTEMS CORP..
What is the Primary UDI-DI identifier for BALLOON SHEATH?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is MH-246R.
What classification code is assigned to this device?
This device is registered under product classification code FED.
Similar Classification Devices (FED)
Other Devices by OLYMPUS MEDICAL SYSTEMS CORP.
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