I-GEL, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US) (UDI 8201030)
Manufactured by Intersurgical Incorporated
Device Regulatory Overview
The I-GEL, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US) (Model/Catalog Number: 8201030) is a medical device manufactured by Intersurgical Incorporated. This product is indexed under FDA Product Code / Category Classification CAE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 8201030
- Product Code / EMDN
- CAE
- Device Name
- I-GEL, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)
- Database Sync Date
- 2026-08-09 09:45:58
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 I-GEL, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)?
The registered manufacturer of record for I-GEL, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US) is Intersurgical Incorporated.
What is the Primary UDI-DI identifier for I-GEL, SUPRAGLOTTIC AIRWAY, SIZE 1.0, NEONATE, 2-5KG (US)?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 8201030.
What classification code is assigned to this device?
This device is registered under product classification code CAE.
Similar Classification Devices (CAE)
Other Devices by Intersurgical Incorporated
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