A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It
| Company | Devices | Share |
|---|---|---|
| Surgical Direct, Inc. | 73 | 22% |
| W.H. Holden, Inc. | 22 | 7% |
| Teleflex Incorporated | 19 | 6% |
| Ace Surgical Supply Co., Inc. | 16 | 5% |
| Sklar Corporation | 16 | 5% |
| Plasdent Corporation | 14 | 4% |
| Darby Dental Supply, Llc | 12 | 4% |
| Dci International, Llc | 11 | 3% |
| Practicon, Inc. | 11 | 3% |
| Devemed Gmbh | 10 | 3% |
| Benco Dental Supply Co. | 10 | 3% |
| Med Saver, Inc. | 10 | 3% |
Company = labeler of record on GUDID. 41 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 |
|---|---|---|
| KBN | GAG, MOUTH | 78 |
| FGN | RETRACTOR, NON-SELF-RETAINING | 67 |
| EIG | RETRACTOR, ALL TYPES | 31 |
| KBN | Gag, Mouth | 25 |
| BRW | Protector, dental | 24 |
| EIF | Accessories, Retractor, Dental | 21 |
Use these as the dimensions to specify in a tender line.
334 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Mouth gag, non-adjustable", from 41 companies. The largest labeler is Surgical Direct, Inc. with 22% of records.
KBN (GAG, MOUTH), FGN (RETRACTOR, NON-SELF-RETAINING), EIG (RETRACTOR, ALL TYPES), KBN (Gag, Mouth)
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.