FDA UDI
In Commercial Distribution
🇺🇸 United States
HNM Women Care
DI: 00812171029366
·
Model: HNM-36-150550
·
HNM STAINLESS, LLC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HNM Women Care
- Primary DI
- 00812171029366
- Version / Model
- HNM-36-150550
- Catalog Number
- HNM-36-150550
- Company Name
- HNM STAINLESS, LLC.
- Labeler DUNS
- 806754185
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-25
- Public Version
- 2
- Public Version Date
- 2023-03-06
- Public Version Status
- Update
- Public Device Record Key
- 3db459ed-f654-4283-8939-6982a0780301
Device Description
PESSARY, RING #6, W/KNOB AND W/SUPPORT, 3.25"
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
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HHW | Pessary, Vaginal | Obstetrics/Gynecology | 884.3575 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59167 | Bladder-supporting pessary | A non-sterile plastic device designed for insertion into the vagina to facilitate management of female urinary incontinence and/or to reduce bladder prolapse. Otherwise known as a bladder-neck support prosthesis, it is designed in the form of a ring with two prongs at one end. The ring is intended to be placed and held in the vagina with the prongs projecting forwards on each side of the urethral opening, thereby supporting the urethra/bladder neck/bladder. This is a reusable device after appropriate cleaning. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00812171029366 | GS1 |