FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Grafco
DI: M36816011
·
Model: 1601
·
GF HEALTH PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
500
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Basic Information
- Brand Name
- Grafco
- Primary DI
- M36816011
- Version / Model
- 1601
- Company Name
- GF HEALTH PRODUCTS, INC.
- Labeler DUNS
- 132016168
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 500
- Record Status
- Published
- Publish Date
- 2016-08-31
- Public Version
- 4
- Public Version Date
- 2025-10-24
- Public Version Status
- Update
- Public Device Record Key
- f6b311ad-d18a-4235-8c1f-cfe1528abfb0
- Distribution End Date
- 2021-05-12
Device Description
Cervical Scrapers
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- 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 | M36816011 | HIBCC | ||||
| Unit of Use | M36816010 | HIBCC |
Customer Contacts
- Phone
- 770-368-4700
- [email protected]