Marking Pen
Marking PEN FOR Trephine & Punch
2manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 37 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
Record
| Listed by | Katena Products, Inc., United States |
|---|---|
| FDA product code | HRP |
| Device type | Pen, Marking, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4570 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-14 |
| Record revised | 2022-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| K20-4500 | 10 | In distribution | |
| K20-4502 | 10 | In distribution | |
| K20-4501 | 10 | In distribution | |
| K20-2120 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medical Action Industries | Medical Action Industries, Inc. | 23 |
| Disposable Micro Marking Pens 10/BOX | Katena Products, Inc. | 1 |
| Disposable Regular Marking Pens 10/BOX | Katena Products, Inc. | 1 |
| Rmac Surgical | Rmac Surgical Inc | 1 |
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.