Intimate Rose
Intimate Rose Medium 4Pack - Rectal Dilators (3-6)
3manufacturers in China registered for this device type
11catalogue 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 | Plus EV Holdings Inc, 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 | 2024-12-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IR-035-7 | In distribution | |
| IR-035-2 | In distribution | |
| IR-035-5 | In distribution | |
| IR-030 | In distribution | |
| IR-035-6 | In distribution | |
| IR-032 | In distribution | |
| IR-035-3 | In distribution | |
| IR-031 | In distribution | |
| IR-035-1 | In distribution | |
| IR-035-4 | In distribution | |
| IR-035-8 | 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 |
| Dilatan Plus | Sapi MED SPA | 3 |
| Intrace USA | Pilotis Tech LLC | 2 |
| 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.