FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04713025224004
·
Model: BA05F-S
·
PANPAC MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04713025224004
- Version / Model
- BA05F-S
- Company Name
- PANPAC MEDICAL CORPORATION
- Labeler DUNS
- 657528899
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-09
- Public Version
- 3
- Public Version Date
- 2022-11-07
- Public Version Status
- Update
- Public Device Record Key
- b51f9099-f376-4337-98f3-fff51d56ff38
Device Description
HSG catheters may be used to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurrent pregnancy loss or unexplained infertility. These devices are also very useful for the assessment of uterine pathology and assessment of patients on tamoxifen therapy.
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
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
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 | 04713025224011 | GS1 | BOX | 10 | In Commercial Distribution | |
| Primary | 04713025224004 | GS1 |