Medline
Tungsten Micro NDL W/Insulation 1 CM
6manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Shuyou Surgical Instrument Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Ningbo Shun YE Medical Company, Ltd. | Cixi Ningbo | Zhejiang | Contract manufacturer | 8 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shenzhen JPY ION-Tech. Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
| Zhejiang Jinhua Huatong Medical Appliance Co., Ltd. | Jinhua | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | HGI |
| Device type | Electrocautery, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4120 |
| 510(k) | K931338 |
| Record published | 2020-05-18 |
| Record revised | 2021-10-04 (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 | Case of 10, case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ESE15516IX | In distribution | |
| ESE1562 | In distribution | |
| ESE1651 | In distribution | |
| ESE1650 | In distribution | |
| ESE1651 | In distribution | |
| ESE1564 | In distribution | |
| ESE1650 | In distribution | |
| ESE1650 | In distribution | |
| ESE1561 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bovie | Aspen Surgical Products, Inc. | 138 |
| DeRoyal | Deroyal Industries, Inc. | 27 |
| Electrocautery, Gynecologic (And Accessories) | C R I | 24 |
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 22 |
| Valleylab | Aspen Surgical Products, Inc. | 20 |
| Argent | Mckesson Medical-Surgical Inc. | 19 |
| Carrera Loop Electrodes | Gynex Corporation | 19 |
| Weck | Teleflex Medical LLC | 18 |
| Radius Loop ELectrodes | Gynex Corporation | 13 |
| Aesculap | Aesculap AG | 11 |
| Leep Radius Electrode | Coopersurgical, Inc. | 10 |
| Premier | Premier Dental Products Co. | 9 |
Showing 12 of 70. All products under Electrocautery, Gynecologic (And Accessories)
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.