FDA UDI
In Commercial Distribution
🇺🇸 United States
Uscope
DI: 06971176280036
·
Model: UE3011
·
Zhuhai Pusen Medical Technology Co, Ltd
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Uscope
- Primary DI
- 06971176280036
- Version / Model
- UE3011
- 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
- 2017-08-08
- Public Version
- 4
- Public Version Date
- 2019-01-23
- Public Version Status
- Update
- Public Device Record Key
- 97999be1-1c97-4024-8f11-9f498521f53d
Device Description
This instrument has been designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38689 | Flexible video ureteroscope, reusable | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the ureter (the upper urinary tract that connects the kidney to the bladder). It is inserted through the external urethral orifice and bladder during ureteroscopy. Anatomical images are transmitted to the user by a video system with a charge-coupled device (CCD) chip at the distal end of the endoscope and the images showing on a monitor. This device is commonly used for biopsies, endoscopic lithotripsy, treatment of upper urinary tract malignancies, incising strictures, and repairing ureteropelvic junction obstructions. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16971176280033 | GS1 | BOX | 1 | In Commercial Distribution | |
| Primary | 06971176280036 | GS1 | ||||
| Package | 26971176280030 | GS1 | BOX | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 2072148535
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K171076 | 000 |