SpecuLume
6 catalogue numbers from 7-51553, listed by Cyalume Technologies, Inc., under Speculum, Vaginal, Nonmetal, Fiberoptic. 1 manufacturer in China is registered for this product code.
1manufacturer
6catalogue 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 | Cyalume Technologies, Inc. |
|---|---|
| FDA product code | HIC |
| Device type | Speculum, Vaginal, Nonmetal, Fiberoptic |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Premarket notification | Exempt |
| Record published | 2021-11-15 |
| Record revised | 2023-01-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 40 to 90 °F |
| Packaging | Inner pack of 25, case of 4 |
| Distribution end date | 2023-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7-51553 | Withdrawn | |
| 7-51552 | Withdrawn | |
| 7-34222 | Withdrawn | |
| 7-34221 | Withdrawn | |
| 7-51551 | Withdrawn | |
| 7-34223 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bioseal Inc. | Bioseal | 5 |
| 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.