Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use FDA UDI
- Device Name
- Hydrodissection cannula, 27 gauge x 8.0mm, horizontally positioned, angled with flattened tip, packaged individually, sterile, disposable, box of 10 FDA UDI
- Model / Reference
- Hydrodissection cannula FDA UDI
- Description
- Hydrodissection cannula, 27 gauge x 8.0mm, horizontally positioned, angled with flattened tip, packaged individually, sterile, disposable, box of 10 FDA UDI
Identifiers
- Catalog Number
- 125158 FDA UDI
- Primary DI / UDI-DI
- 10190660198838 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use 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
Yes
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use
Explore the Ambler Surgical ophthalmic irrigation/infusion/aspiration cannula, a single-use, non-illuminating device designed for precise fluid manipulation in eye surgeries. This rigid tube features angled or blunt tips and is packaged individually in sterile, disposable boxes.
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use.
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- Universal PVC infusion line for 23G cannula system for VFI/VFE — D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. · Class II
- Soft Tip Cannula 20g, 0.8mm tip — Psi/Eye-Ko, Inc. · Class IIa
- I/A HDP. 45 W SLEEVE 1.8 12/BX — Bausch & Lomb, Inc. · Class II
- Visitec® — Beaver-Visitec International, Inc. · Class I
- 85784S 17GA I/A Handpiece, str., tip 45° angled — Bausch & Lomb GmbH · Class IIa
- Anodyne Surgical — Psi/Eye-Ko, Inc. · Class I
- SURGISTAR — Surgistar Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ambler Surgical, LLC
Sources (1)
- FDA UDI 9c2405b9-8b00-40f2-a862-ce6473cdb884 35 fields · synced Jul 30, 2026