FDA UDI
In Commercial Distribution
🇺🇸 United States
KLARITY MEDICAL
DI: 00817355025370
·
Model: RCLG-ESH3-2412CMB
·
Klarity Medical Products, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KLARITY MEDICAL
- Primary DI
- 00817355025370
- Version / Model
- RCLG-ESH3-2412CMB
- Company Name
- Klarity Medical Products, LLC
- Labeler DUNS
- 034824691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-01
- Public Version
- 1
- Public Version Date
- 2021-07-09
- Public Version Status
- New
- Public Device Record Key
- 4dec6414-fa3f-46c7-bec7-a2e802566e09
Device Description
Custom Elekta Light Green E-type Icon™ Head Mask with 12% perforation, 2.4mm with Die Cut 25mm Nosehole
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 40896 | Patient positioning thermoplastic mould material | A thermoplastic material used to create moulds of a patient's body. It is commonly supplied as sheets or meshes of thermoplastic material that have been coated with polyurethane for ease of handling and positioning. Most of these materials are softened by heating in hot water and while softened, are moulded around the patient's anatomy. When cooled, it hardens to form a custom-made mould or cast of that part of the body. After the moulding process is complete, it is typically attached to a board, frame, or another patient positioning system (PPS) or immobilization device. After application, this device cannot be reused (i.e., remoulded). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817355025370 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K022708 | 000 |