Surgilube
Sterile Surgical Lubricant, Metal Tube
33manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (11), Guangdong (7), Zhejiang (6). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Nantong Health & Beyond Hygienic Products Inc. | Rugao | Jiangsu | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Yiwu Ori-Power Medtech Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Xiamen Firstcare IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Exporter | 40 |
| Emsrun Group | Wuxi | Jiangsu | Specification developer | 34 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
Showing 12 of 33. All 33 manufacturers in China registered for Lubricant, Patient
Record
| Listed by | HR Pharmaceuticals Inc. |
|---|---|
| FDA product code | KMJ |
| Device type | Lubricant, Patient |
| Device class | Class 1 |
| Regulation | 21 CFR 880.6375 |
| Premarket notification | Exempt |
| Record published | 2018-08-27 |
| Record revised | 2026-06-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Liquid Chemical |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 6, box of 12, case of 12, box of 144, box of 48, case of 576 |
| Sizes | Weight 3 to 120.49 g |
| Distribution end date | 2026-05-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 281020545 | Weight 5 g | In distribution |
| 281020537 | Weight 120.49 g | In distribution |
| 281020557 | Weight 31 g | In distribution |
| 281020555 | Weight 5 g | In distribution |
| 281020512 | Weight 56.7 g | In distribution |
| 281020543 | Weight 3 g | In distribution |
| 281020502 | Weight 56.7 g | Withdrawn |
| 281020536 | Weight 120.49 g | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HR Lubricating Jelly | HR Pharmaceuticals Inc. | 8 |
| EndoGlide+™ | Jianerkang Medical Co., Ltd. | 8 |
| HCS | Dyad Medical Sourcing, LLC | 7 |
| Cardinal Health | Cardinal Health 200, LLC | 6 |
| Curaplex | Bound Tree Medical, LLC | 6 |
| Aquagel | Parker Laboratories, Inc. | 5 |
| Dukal | Dukal LLC | 5 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 5 |
| EZ Lubricating | HR Pharmaceuticals Inc. | 4 |
| PremierPro | Prestige Ameritech | 4 |
| Medline | Medline Industries, Inc. | 4 |
| Henry Schein | Henry Schein, Inc. | 4 |
Showing 12 of 53. All products under Lubricant, Patient
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.