FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04713025221904
·
Model: FS9000
·
PANPAC MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04713025221904
- Version / Model
- FS9000
- Company Name
- PANPAC MEDICAL CORPORATION
- Labeler DUNS
- 657528899
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-04-29
- Public Version
- 3
- Public Version Date
- 2022-11-07
- Public Version Status
- Update
- Public Device Record Key
- dd95e1fc-1e66-4954-9a6d-eb1871eaf3c9
Device Description
Pessary Fitting Set is designed for the physician to determine the proper size and type of pessary for the patient before prescription.
Device Characteristics
- Single Use
- No
- 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
- MR Unsafe
- 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
- Yes
- Sterilization Methods
- ["Moist Heat or Steam Sterilization", "High-level Disinfectant"]
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 | 04713025221904 | GS1 |
Customer Contacts
- Phone
- +886286472242
- [email protected]