FDA UDI
In Commercial Distribution
🇺🇸 United States
Rovers® Cervex-Brush®
DI: 08719189246056
·
Model: 380100331
·
Rovers Medical Devices B.V.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
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Basic Information
- Brand Name
- Rovers® Cervex-Brush®
- Primary DI
- 08719189246056
- Version / Model
- 380100331
- Company Name
- Rovers Medical Devices B.V.
- Labeler DUNS
- 402155084
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2017-10-19
- Public Version
- 4
- Public Version Date
- 2023-07-13
- Public Version Status
- Update
- Public Device Record Key
- 0c076beb-031f-4d07-abf3-dfdfb6c9ae07
Device Description
Cervical cell sampler, sterile
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HHT | Spatula, Cervical, Cytological | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42537 | Cytology scraper, single-use | A wooden, plastic, or metal instrument used to collect a scraping of cells from tissue for the purposes of a diagnostic examination. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08719189246056 | GS1 | ||||
| Unit of Use | 08719189246353 | GS1 | ||||
| Package | 18719189246053 | GS1 | 20 | In Commercial Distribution | ||
| Package | 08719189246407 | GS1 | 6 | In Commercial Distribution |
Customer Contacts
- Phone
- +31412648870
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K930955 | 000 |