Intrace USA
Goodell Uterine Dilator, 34 cm Length, Corrugated Blades, Graduated Screw Lock, Stainless Steel, Reusable.
3manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Cotronic Technology Limited | Shenzhen, Guang Dong | Guangdong | Contract manufacturer | 5 |
| Shenzhen Linglu Hongtu Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| B.j.zh.f.panther Medical Equipment Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
Record
| Listed by | Pilotis Tech LLC, United States |
|---|---|
| FDA product code | FFP |
| Device type | Dilator, Rectal |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5450 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-07-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Sizes | Length 34 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 14-238-001 | 3/4 mm → 17/18 mm | In distribution |
| 20-494-34 | Length 34 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pediatric Anal Dilator | Specialty Surgical Products, Inc. | 18 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 18 |
| Novo Surgical | Novo Surgical, Inc. | 17 |
| Ambler Surgical | Ambler Surgical, LLC | 14 |
| Intimate Rose | Plus EV Holdings Inc | 11 |
| Dilatan Plus | Sapi MED SPA | 3 |
| Milex Vaginal-Rectal dilator set | Coopersurgical, Inc. | 1 |
| Proximate | Ethicon Endo-Surgery, Inc. | 1 |
| MedSource Cot | Medsource International, LLC | 1 |
| Dilastom | Sapi MED SPA | 1 |
| Sohn’s Dilators | Tools FOR Surgery, LLC | 1 |
| Milex Vaginal Dilator Set | Coopersurgical, Inc. | 1 |
Showing 12 of 13. All products under Dilator, Rectal
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.