FDA UDI
In Commercial Distribution
🇺🇸 United States
Spatula
DI: 50888937001209
·
Model: MX610
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Spatula
- Primary DI
- 50888937001209
- Version / Model
- MX610
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2016-03-21
- Public Version
- 4
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 5ac7e4df-07f4-4f19-9157-100478d3607f
Device Description
Medium, White for maximum cell pick-up in the detection of cervical cancer
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 |
|---|---|---|---|---|
| 32679 | Cervical cytology scraper, single-use | A hand-held, manual, blunt surgical instrument designed to scrape and retrieve cytological material from the surface of the cervix (neck of the uterus) or vaginal area for pathological examination and diagnosis, often for the detection of cervical cancer. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20888937001208 | GS1 | 250 | In Commercial Distribution | ||
| Primary | 50888937001209 | GS1 | ||||
| Unit of Use | 00888937001204 | GS1 |