FDA UDI
In Commercial Distribution
🇺🇸 United States
n.a.
DI: 04048551402535
·
Model: 11272VNIUA
·
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
- 04048551402535
- Version / Model
- 11272VNIUA
- 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
- 2018-05-30
- Public Version
- 5
- Public Version Date
- 2022-10-24
- Public Version Status
- Update
- Public Device Record Key
- 203dbb50-7160-45c2-80aa-912da6187f3d
Device Description
Flexible Video Urethro-Cystoscope, PDD
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
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Peracetic Acid", "Ethylene Oxide", "Hydrogen Peroxide", "High-level Disinfectant"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OAY | Light Source System, Diagnostic Endoscopic | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32019 | Flexible video cystourethroscope | An endoscope with a flexible inserted portion intended for the visual examination and treatment of the bladder and the urethra, including the prostate region. It is inserted into the urethra (the tube that carries urine from the bladder to the outside of the body) through the natural urinary orifice during an endourologic procedure. 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. It is used for biopsy, removal of small stones, treatment of lesions of the urinary bladder/posterior urethra, or to evaluate bladder control/incontinence. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04048551402535 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P050027 | 000 |