Vacuum Tubing
Disposable Tubing for use with the ML7 Microkeratome
2manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Shenzhen Create Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
Record
| Listed by | MED-Logics, Inc., United States |
|---|---|
| FDA product code | KYG |
| Device type | Device, Irrigation, Ocular Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4360 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2020-08-27 |
| Record revised | 2022-07-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Bag of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ML8060VS | In distribution | |
| ML8001VS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 137 |
| Rumex | Rumex International Co. | 20 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 17 |
| Device, Irrigation, Ocular Surgery | Geuder Aktiengesellschaft | 17 |
| High pressure injection/aspiration system for syringe – Connector A | Aktive SRL | 16 |
| Phaco Accessory Set | Medicel AG | 14 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 11 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 9 |
| High pressure injection/aspiration system with syringe – Connector E | Aktive SRL | 8 |
| Medetz Surgical Instruments | Medetz Surgical Instruments | 7 |
| Device, Irrigation, Ocular Surgery | Microvision, Inc. | 3 |
| MorTan | Zien Medical Technologies LLC | 3 |
Showing 12 of 114. All products under Device, Irrigation, Ocular Surgery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K010353 | 2001-04-27 |
| K971173 | 1997-05-22 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.