FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04715309125151
·
Model: UIC5FA
·
PANPAC MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- NA
- Primary DI
- 04715309125151
- Version / Model
- UIC5FA
- Company Name
- PANPAC MEDICAL CORPORATION
- Labeler DUNS
- 657528899
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-15
- Public Version
- 5
- Public Version Date
- 2022-11-07
- Public Version Status
- Update
- Public Device Record Key
- 0ef344ac-a882-49c0-864f-fe9df2f31a6e
Device Description
The catheter is to be used for sonohysterography procedure that aid in the analysis of uterine pathology. A placement sheath eliminates the need for a tenaculum. This catheter is designed for single patient use.
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
- 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 |
|---|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | Obstetrics/Gynecology | 884.4530 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42912 | Hysterosonography/endometrial biopsy catheter | A flexible tube designed for combined saline infusion sonohysterography (SIS) and biopsy functionality providing the physician with increased visibility offered by a sonohysterography during a diagnostic image ultrasound and the ability to take a biopsy of endometrial tissue during the same gynaecological procedure. It is introduced via the vagina and allows the uterus to be filled with saline which is retained with an acorn-tipped stopper placed against the cervical opening; a biopsy can be taken if indicated. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04715309121979 | GS1 | BOX | 25 | In Commercial Distribution | |
| Primary | 04715309125151 | GS1 |
Customer Contacts
- Phone
- +866286472242
- [email protected]