FDA UDI
In Commercial Distribution
🇺🇸 United States
GyneCath H/S Procedure Tray
DI: 20888937016578
·
Model: 19612
·
Coopersurgical, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- GyneCath H/S Procedure Tray
- Primary DI
- 20888937016578
- Version / Model
- 19612
- Company Name
- Coopersurgical, Inc.
- Labeler DUNS
- 801895244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-29
- Public Version
- 3
- Public Version Date
- 2024-02-28
- Public Version Status
- Update
- Public Device Record Key
- 934f2403-6f9c-4b65-8add-449c55c828eb
Device Description
GyneCath H/S Procedure Tray- 5F- for Hysterosonography and Hysterosalpingography
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
- Yes
- 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 |
|---|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37552 | Fallopian tube catheterization kit | A collection of sterile devices designed for the transuterine catheterization of the fallopian tubes to inject dye or contrast medium for the evaluation of tubal patency during salpingoscopy/fluoroscopy, ultrasonography, hysteroscopy, or laparoscopy. It typically consists of a dedicated catheter with a balloon, a syringe to inflate the balloon, a secondary catheter [e.g., a tungsten (W) tipped catheter], a guidewire, and connectors. Some types may also facilitate the entry of other devices/instruments for procedures within the fallopian tubes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 20888937016578 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K020954 | 000 |