FDA UDI
In Commercial Distribution
🇺🇸 United States
MLCi2™
DI: 05060191071024
·
Model: 1525724
·
ELEKTA LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- MLCi2™
- Primary DI
- 05060191071024
- Version / Model
- 1525724
- Company Name
- ELEKTA LIMITED
- Labeler DUNS
- 525557559
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 6
- Public Version Date
- 2022-11-14
- Public Version Status
- Update
- Public Device Record Key
- 7248e349-087f-48f9-bfa9-61bce1234688
Device Description
MLCi2
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
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, linear, medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38137 | Nitrous oxide/oxygen refillable cylinder | A container designed as a refillable cylinder used to hold a compressed mixture of 50% nitrous oxide (N2O) and 50% oxygen (O2) under safe conditions at high pressure (e.g., 50 - 150 Bar). It is typically filled with N2O/O2 when delivered from the gas supplier and includes a valve stem, an opening/closing valve, and will be graded according to size (capacity) and colour-coded to denote N2O/O2 content. The cylinder may be made of steel, aluminium (Al) or other non-ferrous materials and must be used together with a pressure regulator in order to release the N2O/O2 at the correct working pressure. N2O/O2 is used as a potent analgesic for acute trauma, dentistry and short painful procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060191071024 | GS1 |
Customer Contacts
- Phone
- +1(855)693-5358
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K082122 | 000 |