FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 04048551428009
·
Model: 091271-06
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- NA
- Primary DI
- 04048551428009
- Version / Model
- 091271-06
- Catalog Number
- 091271-06
- Company Name
- Karl Storz GmbH & Co. KG
- Labeler DUNS
- 315731430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2025-03-27
- Public Version
- 1
- Public Version Date
- 2025-04-04
- Public Version Status
- New
- Public Device Record Key
- e35a47bc-58b2-496b-8c4d-777f176decc6
Device Description
Video Uretero-Renoscope FLEX-XC1
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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 04048551428016 | GS1 | ||||
| Primary | 04048551428009 | GS1 |
Customer Contacts
- Phone
- +14242188201
- [email protected]