FDA UDI
In Commercial Distribution
🇺🇸 United States
Uro drain tray
DI: 10841736112783
·
Model: 4-040-05
·
SKYTRON LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Uro drain tray
- Primary DI
- 10841736112783
- Version / Model
- 4-040-05
- Company Name
- SKYTRON LLC
- Labeler DUNS
- 078375583
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-15
- Public Version
- 2
- Public Version Date
- 2024-02-05
- Public Version Status
- Update
- Public Device Record Key
- 2a8670fa-44f6-481a-85b2-401edfa9572c
Device Description
Uro drain tray with mounting brackets (3100A)
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LWG | Surgical Table Cushion | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61677 | Urological fluid funnel | A device designed to be attached to a urological operating table (e.g., to a hoop frame) to channel fluids associated with a urological examination or surgery (i.e., body and irrigation fluids) from the table to an appropriate container, surgical suction system, or floor drain. It is typically constructed of flexible plastic material in the shape of funnel; it may include a filter, to trap tissue debris (e.g., urinary stones), and tubing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841736112783 | GS1 |
Customer Contacts
- Phone
- 800-759-8766
- [email protected]