Speculum, Rectal Kit
Speculum, Rectal Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, California Proposition 65 material Compliant, Phthalates & DEHP…
Speculum, Rectal Straight Style Small Speculum Kit ~ 1/4 inflow hose ~ 48 waste hose ~ G-Hose ~ 5g surgical lube packet, California Proposition 65 material Compliant, Phthalates & DEHP Free, CCH Part No. 921478C1 (Class I Device)
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Shanghai FLY Medical Devices Co., Ltd. | Minhang District | Shanghai | Manufacturer | 15 |
| Well Care (Wuhan) Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 4 |
Record
| Listed by | Clearwater Colon Hydrotherapy, Inc., United States |
|---|---|
| FDA product code | FFQ |
| Device type | Speculum, Rectal |
| Device class | Class 1 |
| Regulation | 21 CFR 876.4730 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-09-05 |
| Record revised | 2018-10-22 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Storage | Special storage condition: Stored in Room Temperature |
| Packaging | Plastic bag |
| Sizes | Length 5 to 6 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SPO2 Small Bulb 1448 G-Hose | Length 5 in | In distribution |
| SPO2 Small Straight 1448 G-Hose | Length 5 in | In distribution |
| SPO1 Large Straight 1448 G-Hose | Length 6 in | In distribution |
| SP01 Large Bulb 1448 G-Hose | Length 6 in | In distribution |
| SPO2 Small Bulb 3848 G-Hose | Length 5 in | In distribution |
| SPO1 Large Straight 3848 G-Hose | Length 6 in | In distribution |
| SPO1 Large Bulb 3848 G-Hose | Length 6 in | In distribution |
| SPO2 Small Straight 3848 G-Hose | Length 5 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surtex | Surtex Instruments Ltd | 87 |
| Millennium | Avalign Technologies, Inc. | 37 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 36 |
| Elmed | Elmed, Inc. | 36 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 35 |
| Hayden Medical | Hayden Medical Inc | 30 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 25 |
| HNM Medical | HNM Stainless, LLC. | 25 |
| Aesculap | Aesculap AG | 25 |
| Sklar® | Sklar Corporation | 17 |
| Pilling | Teleflex Medical LLC | 17 |
| Novo Surgical | Novo Surgical, Inc. | 15 |
Showing 12 of 65. All products under Speculum, 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.