Bioseal Inc.
Vaginal Speculum Clear X-Small, Light Source
1manufacturer
5catalogue numbers in this listing
Who Else Makes It
Registered in Zhejiang. 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 |
Record
| Listed by | Bioseal, United States |
|---|---|
| FDA product code | HIC |
| Device type | Speculum, Vaginal, Nonmetal, Fiberoptic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KI805/20 | In distribution | |
| KI801/20 | In distribution | |
| KI807/20 | In distribution | |
| KI802/20 | In distribution | |
| KI901/20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SpecuLume | Cyalume Technologies, Inc. | 6 |
| Gynex SpecuLume EZ | Cyalume Technologies, Inc. | 3 |
| SpecuLume EZ | Cyalume Technologies, Inc. | 3 |
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.