Rmac Surgical
Sterile permanent waterproof utility marker with superfine tip
2manufacturers in China registered for this device type
1catalogue number
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 | Rmac Surgical Inc, Canada |
|---|---|
| FDA product code | HRP |
| Device type | Pen, Marking, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4570 |
| Establishment | Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-01-06 |
| Record revised | 2026-06-11 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 100, carton of 1000 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPL-18401 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medical Action Industries | Medical Action Industries, Inc. | 23 |
| Marking Pen | Katena Products, Inc. | 4 |
| Disposable Micro Marking Pens 10/BOX | Katena Products, Inc. | 1 |
| Disposable Regular Marking Pens 10/BOX | Katena Products, 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.