A dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable rule
| Company | Devices | Share |
|---|---|---|
| Aspen Surgical Products, Inc. | 87 | 27% |
| Xodus Medical, Inc. | 78 | 24% |
| Cardinal Health 200, Llc | 41 | 13% |
| Deroyal Industries, Inc. | 23 | 7% |
| Gri Medical & Electronic Technology Co., Ltd. | 19 | 6% |
| Medline Industries, Inc. | 11 | 3% |
| Medical Action Industries Inc. | 10 | 3% |
| Owens & Minor Distribution, Inc. | 8 | 2% |
| Mckesson Medical-Surgical Inc. | 7 | 2% |
| Katena Products, Inc. | 6 | 2% |
| Batrik Medical Manufacturing Inc | 6 | 2% |
| Med Saver, Inc. | 5 | 2% |
Company = labeler of record on GUDID. 22 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| FZZ | MARKER, SKIN | 258 |
| FZZ | Marker, Skin | 46 |
| HRP | PEN, MARKING, SURGICAL | 14 |
| KDD | Kit, surgical instrument, disposable | 12 |
| LYV | LABEL OR TAG, STERILE | 11 |
| HRP | Pen, marking, surgical | 6 |
Use these as the dimensions to specify in a tender line.
325 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Skin marking pen, single-use", from 22 companies. The largest labeler is Aspen Surgical Products, Inc. with 27% of records.
FZZ (MARKER, SKIN), FZZ (Marker, Skin), HRP (PEN, MARKING, SURGICAL), KDD (Kit, surgical instrument, disposable)
No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.
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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.