Indicator Marker
46 catalogue numbers from TM4019, listed by IZI Medical Products LLC, United States, under Marker, Skin. 55 manufacturers in China are registered for this product code.
55manufacturers in China registered for this device type
46catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (13), Shanghai (10), Zhejiang (10). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Goodwood Medical Care Ltd | Dalian | Liaoning | Contract manufacturer | 19 |
| Guangzhou Shengwei Medical Devices Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 8 |
| Qingdao Changlong Stationary Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 1 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
Showing 12 of 55. All 55 manufacturers in China registered for Marker, Skin
Record
| Listed by | IZI Medical Products LLC, United States |
|---|---|
| FDA product code | FZZ |
| Device type | Marker, Skin |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-11-15 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TM4019 | In distribution | |
| RM2110 | In distribution | |
| TM4102-25 | In distribution | |
| RM2104 | In distribution | |
| TM4001-10 | In distribution | |
| TM4003-25 | In distribution | |
| S-TM4102-20 | In distribution | |
| TM4101-15 | In distribution | |
| TM4003-20 | In distribution | |
| S-TM4001-10 | In distribution | |
| TM4101-25 | In distribution | |
| S-TM4007-15 | In distribution | |
| TM4102-15 | In distribution | |
| TM4003-30 | In distribution | |
| S-TM4001-20 | In distribution | |
| S-TM4003-30 | In distribution | |
| S-TM4102-10 | In distribution | |
| S-TM4007-05 | In distribution | |
| TM4003-40 | In distribution | |
| TM4007-15 | In distribution | |
| S-TMR | In distribution | |
| TM4102-10 | In distribution | |
| TM4101-20 | In distribution | |
| S-TM4101-10 | In distribution | |
| RM2114 | In distribution | |
| S-RM2100 | In distribution | |
| TM4001-20 | In distribution | |
| RM2117 | In distribution | |
| S-TM4003-40 | In distribution | |
| TM4101-10 | In distribution | |
| S-TM4101-15 | In distribution | |
| S-TM4007-10 | In distribution | |
| TM4007-05 | In distribution | |
| S-TM4102-15 | In distribution | |
| S-TM4019 | In distribution | |
| S-TM4003-15 | In distribution | |
| RM2111 | In distribution | |
| S-TM4101-20 | In distribution | |
| S-TM4102-25 | In distribution | |
| S-TM4101-25 | In distribution | |
| TM4003-15 | In distribution | |
| TM4102-20 | In distribution | |
| S-TM4003-20 | In distribution | |
| TM4007-10 | In distribution | |
| S-TM4003-25 | In distribution | |
| S-TMBB | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 57 |
| Devon | Cardinal Health | 34 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 34 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 28 |
| Ambler Surgical | Ambler Surgical, LLC | 25 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 23 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 21 |
| Alleset | GRI Medical & Electronic Technology Co., Ltd. | 18 |
| Medline | Medline Industries, Inc. | 14 |
| HNM Medical | HNM Stainless, LLC. | 14 |
| Marina Medical | Marina Medical Instruments, Inc. | 14 |
| Millennium | Avalign Technologies, Inc. | 12 |
Showing 12 of 206. All products under Marker, Skin
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.