FDA UDI
In Commercial Distribution
🇺🇸 United States
Andwin Scientific
DI: 00187207000146
·
Model: 230075
·
Andwin Scientific
Product Codes
2
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Andwin Scientific
- Primary DI
- 00187207000146
- Version / Model
- 230075
- Company Name
- Andwin Scientific
- Labeler DUNS
- 028449445
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-02
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 294d9549-4a13-4701-b5f1-0321541a09ee
Device Description
PAPKIT, 6000 XSF, 1 Super Frosted Slide, Scraper, Brush & 1oz Fixative Bottle
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHL | Pap Smear Kit | Obstetrics/Gynecology | 884.4530 | 2 |
| HHT | Spatula, Cervical, Cytological | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12955 | Papanicolaou smear kit | A packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20187207000140 | GS1 | CASE | 20 | In Commercial Distribution | |
| Package | 10187207000143 | GS1 | INNER PACK | 25 | In Commercial Distribution | |
| Primary | 00187207000146 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K890283 | 000 |