Cardinal Health
Surgical Marking Pen Traditional Wide Barrel Regular Tip Bulk Non-Sterile
55manufacturers in China registered for this device type
57catalogue 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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FZZ |
| Device type | Marker, Skin |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4660 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-05-28 |
| Record revised | 2022-06-17 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 0 to 0 % RH; Storage environment temperature 0 to 0 °C |
| Packaging | Case of 50, box of 50, case of 12, case of 100, box of 12, case of 4 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 17-7691C | In distribution | ||
| 17F7817A | In distribution | ||
| 17-3491A | In distribution | ||
| 2905BN | 1,000 | In distribution | |
| 250SMNS | In distribution | ||
| 07-4651A | In distribution | ||
| 17-7690C | In distribution | ||
| 17I7817B | In distribution | ||
| 17B7817A | In distribution | ||
| 250GPRL | In distribution | ||
| 212PR | In distribution | ||
| 250PR | In distribution | ||
| 270P | In distribution | ||
| 13-3491 | In distribution | ||
| 250PRL | In distribution | ||
| 250SM | In distribution | ||
| SIDHDCLCTD | In distribution | ||
| 212WPR | In distribution | ||
| 17H7817A | In distribution | ||
| 17C7817A | In distribution | ||
| 225UTL | In distribution | ||
| SBA35TLBLC | In distribution | ||
| 17-7690D | In distribution | ||
| SBA35CLMOC | In distribution | ||
| 17-4166A | In distribution | ||
| SU-1Z | 500 | In distribution | |
| 17I7817A | In distribution | ||
| 270PRL | In distribution | ||
| 250FPRL | In distribution | ||
| GFP-1 | 1,000 | In distribution | |
| WP-1 | 1,000 | In distribution | |
| 250GPR | In distribution | ||
| 17D7817A | In distribution | ||
| 17-7690A | In distribution | ||
| 07A769B | In distribution | ||
| 37-7690A | In distribution | ||
| 17-7690B | In distribution | ||
| 17-7691A | In distribution | ||
| 17-7817A | In distribution | ||
| CSPP-1 | 1,000 | In distribution | |
| 212MIL | In distribution | ||
| 17-0722A | In distribution | ||
| 17G7817A | In distribution | ||
| GP-1Z | 1,000 | In distribution | |
| 07A769A | In distribution | ||
| 17E7817A | In distribution | ||
| 270P-NS | 500 | In distribution | |
| 17B7817B | In distribution | ||
| 17A7690 | In distribution | ||
| 225UTFL | In distribution | ||
| 17A7817B | In distribution | ||
| 17-7691B | In distribution | ||
| PP-100 | 100 | In distribution | |
| 17A7817A | In distribution | ||
| SBAOCLBLHA | In distribution | ||
| 17-7690E | In distribution | ||
| 250P | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Indicator Marker | IZI Medical Products LLC | 46 |
| 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.