FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Single-Use Video Flexible Ureterorenoscope
DI: 06972520301759
·
Model: RP-U-C03R9
·
Guangzhou Red Pine Medical Instrument Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Single-Use Video Flexible Ureterorenoscope
- Primary DI
- 06972520301759
- Version / Model
- RP-U-C03R9
- Company Name
- Guangzhou Red Pine Medical Instrument Co., Ltd.
- Labeler DUNS
- 417649868
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-31
- Public Version
- 1
- Public Version Date
- 2026-01-08
- Public Version Status
- New
- Public Device Record Key
- 44268f33-05f0-4b8d-92c3-d45ed20a09f0
- Distribution End Date
- 2025-12-31
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
- MR Unsafe
- 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
- Yes
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64003 | Flexible video ureterorenoscope, single-use | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter and renal pelvis. It is inserted through the external urethral orifice or a surgically-created percutaneous route during a urological procedure. Anatomical images are transmitted to the user by a video system with an electronic image sensor at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for the removal or crushing of stones, and evaluation of pyelitis and renal failure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06972520301759 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K251951 | 000 |