Identity
- Trade Name
- Aegis Illuminated Mediastinal Access Port FDA UDI
- Generic Name
- Rigid optical mediastinoscope FDA UDI
- Model / Reference
- 900-01200 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00863189000304 FDA UDI
- FDA Product Code
- EWY FDA UDI
- GMDN Term
- Rigid optical mediastinoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4720 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
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Rigid optical mediastinoscope
Aegis Illuminated Mediastinal Access Port by Aegis Surgical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rigid optical mediastinoscope.
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- PILLING — TELEFLEX INCORPORATED · Class II
- PILLING — TELEFLEX INCORPORATED · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Aegis Surgical, Ltd.
Sources (1)
- FDA UDI 842fe71f-6280-448b-b061-6a7134c4f35e 32 fields · synced May 30, 2026