Identity
- Trade Name
- Aurotrocar FDA UDI
- Generic Name
- Ophthalmic cannulation set, single-use FDA UDI
- Device Name
- Trocar set is a sterile single use medical device consisting of Stainless steel Trocar needle glued to a plastic handle in which the Cannula appended with valved silicone closure valve slides over it. This assembly is secured by a plastic cap. It is supplied along with one silicone tube inserted with an infusion adaptor and a Luer lock adaptor on either ends which is called as infusion line. A Trocar set encompasses 3 Trocar handle with cap and one infusion line. FDA UDI
- Model / Reference
- ATS-23G FDA UDI
- Description
- Trocar set is a sterile single use medical device consisting of Stainless steel Trocar needle glued to a plastic handle in which the Cannula appended with valved silicone closure valve slides over it. This assembly is secured by a plastic cap. It is supplied along with one silicone tube inserted with an infusion adaptor and a Luer lock adaptor on either ends which is called as infusion line. A Trocar set encompasses 3 Trocar handle with cap and one infusion line. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10803878053058 FDA UDI
- FDA Product Code
- NGY FDA UDI
- GMDN Term
- Ophthalmic cannulation set, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4350 FDA UDI
- Commercial Distribution
- Not 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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Aurotrocar by Aurolab — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aurolab
Sources (1)
- FDA UDI 8ee2f594-373e-4f17-afb5-e1e4e424f90b 35 fields · synced Jun 1, 2026