Isosense (UDI 08997030302087)
Manufactured by PT. Medisafe Technologies
Device Regulatory Overview
The Isosense (Model/Catalog Number: Powder Free Polyisoprene Sterile Surgical Gloves, Size 7.0 (1R-SG-119-WH)) is a medical device manufactured by PT. Medisafe Technologies. This product is indexed under FDA Product Code / Category Classification T01010203 within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- Powder Free Polyisoprene Sterile Surgical Gloves, Size 7.0 (1R-SG-119-WH)
- Product Code / EMDN
- T01010203
- Device Name
- Powder Free Polyisoprene Sterile Surgical Gloves
- Database Sync Date
- 2026-08-09 16:59:08
Full Regulatory Attributes
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{
"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 Isosense?
The registered manufacturer of record for Isosense is PT. Medisafe Technologies.
What is the Primary UDI-DI identifier for Isosense?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 08997030302087.
What classification code is assigned to this device?
This device is registered under product classification code T01010203.
Similar Classification Devices (T01010203)
Other Devices by PT. Medisafe Technologies
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