FDA UDI
In Commercial Distribution
🇺🇸 United States
Skytron
DI: 10841736122485
·
Model: 6-020-10-9
·
SKYTRON LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Skytron
- Primary DI
- 10841736122485
- Version / Model
- 6-020-10-9
- Catalog Number
- 6-020-10-9
- Company Name
- SKYTRON LLC
- Labeler DUNS
- 078375583
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-01-29
- Public Version
- 3
- Public Version Date
- 2023-10-18
- Public Version Status
- Update
- Public Device Record Key
- 0e6e5289-7b7c-44f4-9721-dd7c59fd83ae
Device Description
EZ Roll Cart Horizontal Divider Assy
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| FQO | TABLE, OPERATING-ROOM, AC-POWERED | General, Plastic Surgery | 878.4960 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36614 | Examination/operating table component trolley | A dedicated cart designed as a framework on wheels intended to transport a component/accessory of an examination and/or operating table (e.g., patient supports, stirrups, tabletops) within a hospital/institution department or ward. It may include baskets, shelves, hooks and/or organizers for storing and/or transporting components. This trolley (cart) may be used in association with an examination/operating table and may have a fixed height or be hydraulically height-adjustable by a pump (e.g., to position a tabletop onto or off a column). It is not intended to be used to perform procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841736122485 | GS1 |
Customer Contacts
- Phone
- +1(800) 759-8766
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -25 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 5 – 95 Percent (%) Relative Humidity