FDA UDI
In Commercial Distribution
🇺🇸 United States
Prosurg
DI: 00851545007807
·
Model: NFC9
·
PROSURG INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Prosurg
- Primary DI
- 00851545007807
- Version / Model
- NFC9
- Catalog Number
- NFC9
- Company Name
- PROSURG INC
- Labeler DUNS
- 188684609
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-12
- Public Version
- 1
- Public Version Date
- 2020-05-20
- Public Version Status
- New
- Public Device Record Key
- 219ba6d7-22cd-4471-8e98-b78cd9b4b5e4
Device Description
Neoflex Cystoscope 9.0 FR
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
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61728 | Flexible video cystoscope, single-use | A sterile endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urinary tract by introduction through the urethra. Anatomical images are transmitted from a distal camera and displayed on a monitor. It is typically used to examine/diagnose incontinence, urinary retention, recurrent urinary tract infections, and/or to remove tissue specimens/stones/small tumours from the bladder; it may have specialized tools for functions such as ureteral stent removal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10851545007804 | GS1 | Inner Pak | 1 | In Commercial Distribution | |
| Primary | 00851545007807 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K120766 | 000 |