EZ Access™
Wound Protector/ Retractor
3manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. | Siyang | Jiangsu | Manufacturer | 21 |
| Jiangsu Haize Medical Scientific Development Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 9 |
| Guangzhou T.K Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
Record
| Listed by | V L V Associates (inc) |
|---|---|
| FDA product code | KGW |
| Device type | Ring (Wound Protector), Drape Retention, Internal |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2017-12-18 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1425-L | 9 – 14cm | In distribution |
| 1425-S | 2.5 – 6cm | In distribution |
| 1425-XL | 11 – 17cm | In distribution |
| 1425-XS | 2 – 4cm | In distribution |
| 1425-M | 5 – 9cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alexis Wound Protector-Retractor | Applied Medical Resources Corp. | 8 |
| Alexis ® Orthopaedic Protector | Applied Medical Resources Corp. | 8 |
| Alexis O Wound Protector-Retractor | Applied Medical Resources Corp. | 6 |
| Convertors | Cardinal Health 200, LLC | 3 |
| Alexis Laparoscopic System | Applied Medical Resources Corp. | 2 |
| Alexis® Lighted Wound Protector-Retractor | Applied Medical Resources Corp. | 2 |
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.