FDA UDI
In Commercial Distribution
🇺🇸 United States
HNM Women Care
DI: 00812171023906
·
Model: HBI-UIC5F
·
HNM STAINLESS, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Basic Information
- Brand Name
- HNM Women Care
- Primary DI
- 00812171023906
- Version / Model
- HBI-UIC5F
- Catalog Number
- HBI-UIC5F
- Company Name
- HNM STAINLESS, LLC.
- Labeler DUNS
- 806754185
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2019-05-30
- Public Version
- 2
- Public Version Date
- 2023-03-06
- Public Version Status
- Update
- Public Device Record Key
- bd86c511-fd10-4eb9-999c-732f0669adc0
Device Description
BELLOTA SONOHYSTEROGRAPHY CATHETER W/O CERVICAL CONE, 5 Fr, 350mm, NON-BALLOON, STERILE, BOX OF 25
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
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00812171023906 | GS1 | ||||
| Unit of Use | 00842962100189 | GS1 |