FDA UDI
In Commercial Distribution
🇺🇸 United States
Gynex
DI: GYNX102001
·
Model: 10-200
·
GYNEX CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
2
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Basic Information
- Brand Name
- Gynex
- Primary DI
- GYNX102001
- Version / Model
- 10-200
- Company Name
- GYNEX CORPORATION
- Labeler DUNS
- 012997685
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2023-06-28
- Public Version
- 1
- Public Version Date
- 2023-07-06
- Public Version Status
- New
- Public Device Record Key
- 01466328-7ee8-4fc3-95c4-e6bd03a35e85
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNA | Instrument, Manual, Specialized Obstetric-Gynecologic | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10695 | Bartholin's gland catheter | A short (e.g., 5 cm) plastic tube designed to form a tract from either of the two small reddish glands (Bartholin's glands), one on each side of the vaginal orifice, to the space where the urethra and the vagina open (vaginal vestibulum). It may include a balloon at the tip to ensure retention within the gland. The device is typically used for drainage in the treatment of Bartholin's gland cysts and abscesses. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | GYNX102001 | HIBCC | ||||
| Unit of Use | GYNX102000 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130087 | 000 |