A dedicated pen (typically a felt-tip 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. This is a reusable device.
| Company | Devices | Share |
|---|---|---|
| Ambler Surgical Corp. | 31 | 48% |
| Hnm Stainless, Llc. | 14 | 22% |
| Integra Lifesciences Production Corporation | 6 | 9% |
| Medicon Eg. Chirurgiemechaniker-Genossenschaft | 5 | 8% |
| Aesculap, Inc. | 2 | 3% |
| Park Dental Research Corp | 2 | 3% |
| Smith & Nephew, Inc. | 1 | 2% |
| Avalign Technologies, Inc. | 1 | 2% |
| Seaspine Orthopedics Corporation | 1 | 2% |
| Medline Industries, Inc. | 1 | 2% |
Company = labeler of record on GUDID. 10 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 | 35 |
| FZZ | Marker, Skin | 17 |
| HTD | FORCEPS | 5 |
| FTY | TAPE, MEASURING, RULERS AND CALIPERS | 4 |
| LXH | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 2 |
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | 2 |
Use these as the dimensions to specify in a tender line.
64 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Skin marking pen, reusable", from 10 companies. The largest labeler is Ambler Surgical Corp. with 48% of records.
FZZ (MARKER, SKIN), FZZ (Marker, Skin), HTD (FORCEPS), FTY (TAPE, MEASURING, RULERS AND CALIPERS)
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.