Identity
- Trade Name
- Ambler Surgical FDA UDI
- Generic Name
- Ophthalmic irrigation/infusion/aspiration tubing, reusable FDA UDI
- Device Name
- Replacement silicone tubing, 10', 0.078'' ID x 0.126'' OD x 0.024'' wall FDA UDI
- Model / Reference
- Replacement silicone tubing FDA UDI
- Description
- Replacement silicone tubing, 10', 0.078'' ID x 0.126'' OD x 0.024'' wall FDA UDI
Identifiers
- Catalog Number
- 9017E FDA UDI
- Primary DI / UDI-DI
- 00190660217235 FDA UDI
- FDA Product Code
- HMX FDA UDI
- GMDN Term
- Ophthalmic irrigation/infusion/aspiration tubing, 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
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
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 tubing, reusable
Ambler Surgical by Ambler Surgical, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ophthalmic irrigation/infusion/aspiration tubing, reusable.
- Bausch + Lomb — Bausch & Lomb Incorporated · Class I
- MR PHACO — Crestpoint Management Ltd. · Class I
- Tubing Kit, M2000 — MEDICAL TECHNICAL PRODUCTS, INC · Class II
- IRRIGATION/ASPIRATING HANDLE — SONTEC INSTRUMENTS, INC. · Class I
- Bausch + Lomb — Bausch & Lomb Incorporated · Class I
- Tubing Cartridge, M3000 — MEDICAL TECHNICAL PRODUCTS, INC · Class II
- McINTYRE INFUSION HANDLE — SONTEC INSTRUMENTS, INC. · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
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 b2312837-f198-41cf-9476-978c7c847088 35 fields · synced Jun 8, 2026