FDA UDI
In Commercial Distribution
🇺🇸 United States
Single Use Flexible Video Cystoscope
DI: 06971176280364
·
Model: PC200-S
·
Zhuhai Pusen Medical Technology Co, Ltd
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Single Use Flexible Video Cystoscope
- Primary DI
- 06971176280364
- Version / Model
- PC200-S
- Company Name
- Zhuhai Pusen Medical Technology Co, Ltd
- Labeler DUNS
- 544427443
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-02
- Public Version
- 1
- Public Version Date
- 2022-12-12
- Public Version Status
- New
- Public Device Record Key
- 60be3301-13f4-4b35-a53f-e4dc0203d6b7
Device Description
This device is a sterile, single use video cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The Single Use Flexible Video Cystoscope is intended to provide visualization via video processor and can be used with endoscopic accessories.
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
- Yes
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 06971176280364 | GS1 | ||||
| Package | 16971176280361 | GS1 | box | 10 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K222602 | 000 |