Medline
Laparoscopic Gastric Bypass
4manufacturers in China registered for this device type
19catalogue numbers in this listing
Who Else Makes It
Concentrated in Anhui (2), Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medical Sterilizing Co., Ltd. | Hefei | Anhui | Contract manufacturer | 8 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | FDE |
| Device type | Laparoscopy Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Premarket notification | Exempt |
| Record published | 2021-08-20 |
| Record revised | 2022-06-17 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CDS982888J | In distribution | |
| CDS983418F | In distribution | |
| DYNDM1084C | In distribution | |
| DYNJ42986F | In distribution | |
| CDS983412F | In distribution | |
| DYNDM1084B | In distribution | |
| CDS982332L | In distribution | |
| CDS983356U | In distribution | |
| DYNJ35090D | In distribution | |
| CDS984033K | In distribution | |
| DYNJ0495358R | In distribution | |
| CDS983354P | In distribution | |
| CDS981184D | In distribution | |
| DYNJ31342N | In distribution | |
| CDS760057I | In distribution | |
| CDS760054AD | In distribution | |
| CDS980890K | In distribution | |
| CDS981116Q | In distribution | |
| DYKE1485A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 23,145 |
| Cardinal Health | Cardinal Health 200, LLC | 9,245 |
| ACS | American Contract Systems, Inc. | 988 |
| Aligned Medical Solutions | Aligned Medical Solutions | 156 |
| DeRoyal | Deroyal Industries, Inc. | 141 |
| Regard™ | ROi CPS LLC | 122 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 61 |
| Halyard | Avid Medical, Inc. | 13 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 9 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 7 |
| Henry Schein | Henry Schein, Inc. | 7 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
Showing 12 of 17. All products under Laparoscopy Kit
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-04-27 | Class II | Process control | Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application. | 49,654 kits total |
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.