FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048551169629
·
Model: 496U
·
Karl Storz GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- n.a.
- Primary DI
- 04048551169629
- Version / Model
- 496U
- Company Name
- Karl Storz GmbH & Co. KG
- Labeler DUNS
- 315731430
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-24
- Public Version
- 2
- Public Version Date
- 2019-02-07
- Public Version Status
- Update
- Public Device Record Key
- f180cab5-36df-46be-9847-8df90828c903
Device Description
Fiber Optic Ureter Probe
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Liquid Chemical"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCS | Light, catheter, fiberoptic, glass, ureteral | Gastroenterology, Urology | 876.4020 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41605 | Ureteral transilluminator, reusable | A flexible tube containing a fibreoptic bundle that emits light throughout its length, intended to be inserted into the ureter for (trans)illumination to facilitate visualization of the ureter. It is used to aid dissection during laparoscopic and/or open abdominal surgery; sometimes it is referred to as illuminating catheter. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551169629 | GS1 |