FDA UDI
In Commercial Distribution
🇺🇸 United States
MedGyn Laminaria
DI: M803021026
·
Model: size 6 with buttons
·
MEDGYN PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- MedGyn Laminaria
- Primary DI
- M803021026
- Version / Model
- size 6 with buttons
- Catalog Number
- 021026
- Company Name
- MEDGYN PRODUCTS, INC.
- Labeler DUNS
- 103913430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-29
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 37ebb0cb-8f86-4bde-b0dc-3eb499d91b98
Device Description
Dilator of Uterine Cervix
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 |
|---|---|---|---|---|
| HDY | Dilator, Cervical, Hygroscopic-Laminaria | Obstetrics/Gynecology | 884.4260 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 34965 | Hygroscopic cervical dilator | A sterile plug of expansible material intended to dilate the uterine cervix by gradually swelling to several times its original diameter through the absorption of moisture from the cervix over a period of several hours (typically <24 hours). It is made of synthetic polymer and/or plant-derived materials and typically has features (e.g., attached cord, handle) intended to assist anchoring, locating, and easy removal. The device is typically used to dilate the cervical canal for uterine curettage, labour induction, midterm abortions, intrauterine device (IUD) placement and removal, and radium placement. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M803021026 | HIBCC |