FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 05060247262123
·
Model: Niagara MED1455
·
MEDISAFE UK LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 05060247262123
- Version / Model
- Niagara MED1455
- Catalog Number
- MED1455
- Company Name
- MEDISAFE UK LIMITED
- Labeler DUNS
- 505942961
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 5
- Public Version Date
- 2021-03-09
- Public Version Status
- Update
- Public Device Record Key
- 07c1a61b-0f1b-42a4-b7d6-d8d0980ea7a4
Device Description
The Niagara MED1455 Instrument Carrier accommodates up to 20 EndoWrist instruments. Additional Levels on the carrier are provided for the loading of accessories used with the da Vinci systems.
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
- 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 |
|---|---|---|---|---|
| MEC | Disinfector, medical devices | General Hospital | 880.6992 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62151 | Sterilizer/disinfector rack | A non-sterile rack or group of shelves intended to hold medical devices in a sterilizer or chemical washer/disinfector during the sterilization or washing/disinfection cycle. It may also be used to transport medical devices to and from the process and for their temporary storage. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060247262123 | GS1 |
Customer Contacts
- Phone
- +1(999)999-9999
- [email protected]