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I-Gel Plus, Supraglottic Airway, Size 3, Small Adult, 30-60kg
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- I-GEL PLUS, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG FDA UDI
- Generic Name
- Laryngeal mask airway, single-use FDA UDI
- Device Name
- I-GEL PLUS, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG FDA UDI
- Model / Reference
- 8603000 FDA UDI
- Description
- I-GEL PLUS, SUPRAGLOTTIC AIRWAY, SIZE 3, SMALL ADULT, 30-60KG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05030267143771 FDA UDI
- FDA Product Code
- CAE FDA UDI
- GMDN Term
- Laryngeal mask airway, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5110 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Category: Laryngeal mask airway, single-use
I-Gel Plus, Supraglottic Airway, Size 3, Small Adult, 30-60kg by Intersurgical Incorporated — Class I — FDA UDI — listed in FDA GUDID
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Intersurgical Incorporated
Sources (1)
- FDA UDI b1b835bd-f733-4b4d-85d1-c6821154a0ae 34 fields · synced Jun 8, 2026