Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
- Device Name
- Miyoshi ultimate vertical dual flow hydrodissectional cannula, 23 gauge, angled 45 degrees tip, 1.5mm from bend to tip, 0.2mm dual ports set at 120 degrees, smooth closed sandblasted tip, 22mm overall length excluding hub FDA UDI
- Model / Reference
- Miyoshi ultimate vertical dual flow hydrodissectional cannula FDA UDI
- Description
- Miyoshi ultimate vertical dual flow hydrodissectional cannula, 23 gauge, angled 45 degrees tip, 1.5mm from bend to tip, 0.2mm dual ports set at 120 degrees, smooth closed sandblasted tip, 22mm overall length excluding hub FDA UDI
Identifiers
- Catalog Number
- 5801E FDA UDI
- Primary DI / UDI-DI
- 00190660006242 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 9940c1e5-3617-469f-bb3f-25b271b9c3d9 35 fields · synced Jun 8, 2026