FDA UDI
In Commercial Distribution
🇺🇸 United States
Gynosampler
DI: 05425017500377
·
Model: #9164
·
Gynetics Medical Products NV
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Gynosampler
- Primary DI
- 05425017500377
- Version / Model
- #9164
- Company Name
- Gynetics Medical Products NV
- Labeler DUNS
- 283088573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-10-04
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- c96be6b0-7813-4653-b746-1c139e6f4b25
Device Description
The Gynosampler is an endometrial suction curette for a histologic lining biopsy.
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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HFF | Aspirator, Endometrial | Obstetrics/Gynecology | 884.1060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11531 | Endometrial biopsy kit | A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05425017500377 | GS1 | ||||
| Package | 15425017500374 | GS1 | 25 | In Commercial Distribution | ||
| Package | 75425017500376 | GS1 | 250 | In Commercial Distribution |
Customer Contacts
- Phone
- +3211645872
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K903002 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 2.93 | Millimeter | |
| Length | 262 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius