TLS
4mm Flat Drain with Side Holes, Sterile
58manufacturers in China registered for this device type
3catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (19), Guangdong (14), Zhejiang (9). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Ningbo Albert Novosino Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Changshu Beyond Medical Device Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 9 |
| Fansheng Technology (Guangdong) Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 8 |
Showing 12 of 58. All 58 manufacturers in China registered for Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Record
| Listed by | Stryker Leibinger Gmbh & Co. KG, Germany |
|---|---|
| FDA product code | GCY |
| Device type | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4680 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K833586 |
| Record published | 2016-08-24 |
| Record revised | 2025-03-17 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Width 4 mm |
| Distribution end date | 2025-03-03 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 6660 | Width 4.0 mm | 6 | Withdrawn |
| 6640 | 6 | Withdrawn | |
| 6650 | 6 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 169 |
| Cardinal Health | Cardinal Health 200, LLC | 50 |
| Closed Suction | Sunset Healthcare Solutions, Inc. | 49 |
| Closed Wound Suction | C.R. Bard, Inc. | 37 |
| Barovac® Evacuator Closed Wound Drainage System(SS) | Sewoon Medical Co., Ltd. | 33 |
| Hemovac® Wound Drainage System | Zimmer Orthopaedic Surgical Products | 23 |
| Barovac® Evacuator Closed Wound Drainage System(PP) | Sewoon Medical Co., Ltd. | 22 |
| Deluxe Closed Suction System 72hr | Sunset Healthcare Solutions, Inc. | 20 |
| Tru-Close Suction Drainage System | Uresil, LLC | 19 |
| Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 19 |
| Tracheostomy and Suction Accessory | Sunset Healthcare Solutions, Inc. | 18 |
| S-Vac® Fluted Channel Drain | Aspen Surgical Products, Inc. | 17 |
Showing 12 of 110. All products under Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Stryker Leibinger Gmbh & Co. KG | 510(k) number | 2017-01-03 | Class II | Labeling mix-ups | An incorrect sterility status on the label, non-sterile products labeled as sterile | 619 | 2017-07-27 |
| Stryker Leibinger Gmbh & Co. KG | 510(k) number | 2017-01-03 | Class II | Labeling mix-ups | An incorrect sterility status on the label, non-sterile products labeled as sterile | 619 | 2017-07-27 |
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.