Medical Action Industries
Pen: Std Pt CHG Res Ruler LBL 100/Cs
2manufacturers in China registered for this device type
23catalogue 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 | Medical Action Industries, Inc., United States |
|---|---|
| FDA product code | HRP |
| Device type | Pen, Marking, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4570 |
| Premarket notification | Exempt |
| Record published | 2016-08-20 |
| Record revised | 2021-10-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: store at room temperature |
| Packaging | Pack of 4, pack of 25 |
| Distribution end date | 2022-11-23 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Q215 | In distribution | ||
| Q230 | In distribution | ||
| Q200 | In distribution | ||
| NS200 | 500 | In distribution | |
| NS130 | 500 | In distribution | |
| NS100 | 500 | In distribution | |
| NS115 | 500 | In distribution | |
| 130 | In distribution | ||
| 140 | In distribution | ||
| CHG330 | In distribution | ||
| 115 | In distribution | ||
| NS215 | 500 | In distribution | |
| CHG315 | In distribution | ||
| NS140 | 1,000 | In distribution | |
| Q100 | In distribution | ||
| NS300 | 500 | In distribution | |
| CHG300 | In distribution | ||
| 74088 | 3,000 | Withdrawn | |
| 140-NL | Withdrawn | ||
| 115BR | Withdrawn | ||
| Q200BR | Withdrawn | ||
| NS110 | 500 | Withdrawn | |
| 74089 | 3,000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.