FDA UDI
In Commercial Distribution
🇺🇸 United States
Silicone connection set for cystoscopes and ureteroscopes WOLF, STORZ, OLYMPUS,
DI: 03701354403000
·
Model: Wol U
·
PLASMABIOTICS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Silicone connection set for cystoscopes and ureteroscopes WOLF, STORZ, OLYMPUS,
- Primary DI
- 03701354403000
- Version / Model
- Wol U
- Company Name
- PLASMABIOTICS
- Labeler DUNS
- 262972663
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-13
- Public Version
- 1
- Public Version Date
- 2021-05-21
- Public Version Status
- New
- Public Device Record Key
- 8cf22821-8982-4506-904d-9879206f6c0b
Device Description
Silicone connection set for cystoscopes and ureteroscopes WOLF, STORZ, OLYMPUS, PENTAX with two luer-lock channel entrances
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- Yes
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Clinical Chemistry | 862.2050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61445 | Endoscope clean-storage system | A mobile, mains electricity (AC-powered) assembly of devices intended to prepare, bag, label and register disinfected and sterilized endoscopes prior to long-term storage. It typically includes: 1) a fluid preparation assembly such as fluid pump, tubing and a preparation solution (e.g., hydrogen peroxide solution); 2) devices intended to achieve sealed-storage such as trays, sterile liners, vacuum bags, and a vacuum pump; 3) labelling/registration devices (i.e., bar-code printer and bar-code reader); and 4) a computer with integrated software for process/data management. It is not intended to clean, disinfect or sterilize but to maintain the sterilized/disinfected state of the endoscope. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 03701354403000 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 34 | Centimeter | |
| Width | 23 | Centimeter | |
| Height | 3 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- .9 – 1.1 Inches of Mercury