A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device m
| Company | Devices | Share |
|---|---|---|
| O&M Halyard, Inc. | 506 | 50% |
| Medline Industries, Inc. | 191 | 19% |
| Gri Medical & Electronic Technology Co., Ltd. | 97 | 10% |
| Cardinal Health 200, Llc | 84 | 8% |
| Microtek Medical Llc | 58 | 6% |
| Centurion Medical Products Corporation | 20 | 2% |
| Angiosystems, Incorporated | 19 | 2% |
| Darby Dental Supply, Llc | 10 | 1% |
| Custom Assemblies, Inc. | 9 | 1% |
| Prestige Ameritech, Ltd. | 6 | 1% |
| Ace Surgical Supply Co., Inc. | 3 | 0% |
| Vortek Surgical, Llc | 3 | 0% |
Company = labeler of record on GUDID. 16 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 |
|---|---|---|
| PUI | Drape, surgical, exempt | 813 |
| KKX | Drape, surgical | 659 |
| KKX | Drape, Surgical | 38 |
| PUI | Drape, Surgical, Exempt | 15 |
| ERY | Drape, surgical, ent | 12 |
| PEM | Dental barriers and sleeves | 10 |
Use these as the dimensions to specify in a tender line.
1,011 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Patient surgical drape, single-use, non-sterile", from 16 companies. The largest labeler is O&M Halyard, Inc. with 50% of records.
PUI (Drape, surgical, exempt), KKX (Drape, surgical), KKX (Drape, Surgical), PUI (Drape, Surgical, Exempt)
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.