Identity
- Trade Name
- Universal Gas Mixing Kit FDA UDI
- Generic Name
- Vitreoretinal gas injection set FDA UDI
- Device Name
- Convenient kit for the controlled and accurate mixing and dispensing of gases. Includes 3-way stopcock for drawing of gas or air, 0.2 micron filters provide for sterilization of gas and/or air, and 60cc syringe pre-marked with mixture percentages to eliminate guesswork during prepping. Sterile, single use. FDA UDI
- Model / Reference
- 9060-61 FDA UDI
- Description
- Convenient kit for the controlled and accurate mixing and dispensing of gases. Includes 3-way stopcock for drawing of gas or air, 0.2 micron filters provide for sterilization of gas and/or air, and 60cc syringe pre-marked with mixture percentages to eliminate guesswork during prepping. Sterile, single use. FDA UDI
Identifiers
- Catalog Number
- TR9060-61 FDA UDI
- Primary DI / UDI-DI
- 00853480006150 FDA UDI
- 510(k) Number
- K923397 FDA UDI
- FDA Product Code
- BXX FDA UDI
- GMDN Term
- Vitreoretinal gas injection set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.2620 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: Vitreoretinal gas injection set
Universal Gas Mixing Kit by Escalon Medical Corp — 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 |
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Manufacturer
- Manufacturer
- Escalon Medical Corp
Sources (1)
- FDA UDI f1800652-bfbd-4501-8ffc-2c712baf177b 36 fields · synced May 30, 2026