FDA UDI
In Commercial Distribution
🇺🇸 United States
MedGyn Pipette II
DI: M803022734
·
Model: MedGyn Pipette II 3.1mm O.D.
·
MEDGYN PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MedGyn Pipette II
- Primary DI
- M803022734
- Version / Model
- MedGyn Pipette II 3.1mm O.D.
- Catalog Number
- 022734
- Company Name
- MEDGYN PRODUCTS, INC.
- Labeler DUNS
- 103913430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-14
- Public Version
- 1
- Public Version Date
- 2020-12-22
- Public Version Status
- New
- Public Device Record Key
- 6d4e1499-2761-40f3-8269-8a29e32dc3a9
Device Description
MedGyn Pipette II 3.1mm O.D.
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| HHI | System, Abortion, Vacuum | Obstetrics/Gynecology | 884.5070 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32634 | Endometrial cytology brush | A device with bristle-like projections designed to remove samples of the endometrium (the mucosal lining of the uterus) by brushing its interior surface. It is used in the study of endometrial cytology (cells). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M803022734 | HIBCC |