| Primary Device ID | 07898027903601 |
| NIH Device Record Key | 6cca1a6b-3a71-43e7-acd2-df71ab6d575e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KOLPLAST |
| Version Model Number | Wireless |
| Company DUNS | 903963889 |
| Company Name | Kolplast C I |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +551149610972 |
| daniela.feracin@kolplast.com.br |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07898027903601 [Primary] |
| FTD | Lamp, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-09-23 |
| Device Publish Date | 2019-09-13 |
| 07898027905902 | "Cervical Sample Collection Kit, intended for collection of cytological specimens from the ectoc |
| 07898027903601 | Wireless LED light source for vaginal speculum. Provides illumination during pelvic examination |
| 07898027903526 | LED light source for vaginal speculum. Provides illumination during pelvic examination and other |
| 07898027903519 | Disposable Vaginal Speculum |
| 07898027909894 | SWAB HASTE NASAL D2,5 ESTERIL |
| 07898027908682 | SOL SALINA 3ML/2SWAB T10 EST |
| 07898027908460 | ESCOVA PP/ESPATULA PLAST 25UN |
| 07898027905353 | SWAB HASTE REGULAR D2,5 FP EST |
| 07898027903311 | RETOSIGMOIDOSCOPIO |
| 07898027901355 | RETOSIGMOIDOSCOPIO |