FDA UDI
In Commercial Distribution
🇺🇸 United States
KLARITY MEDICAL
DI: 00817355028678
·
Model: R61602
·
Klarity Medical Products, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- KLARITY MEDICAL
- Primary DI
- 00817355028678
- Version / Model
- R61602
- Company Name
- Klarity Medical Products, LLC
- Labeler DUNS
- 034824691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-14
- Public Version
- 2
- Public Version Date
- 2026-02-20
- Public Version Status
- Update
- Public Device Record Key
- a02637ff-a526-4e5a-84f2-7e1b37ecbac3
Device Description
Klarity Uno™ SBRT Set, carbon fiber. Includes Baseplate, Abdominal Compression Bridge, Inflatable Air Bag, Knee Bridge, Knee Bridge Vacuum Bag, Knee Riser, 2 Knee Elevation Blocks, Foot Holder, R7644-32.5BC SBRT Vacuum Bag, and Indexing Bar
Device Characteristics
- Single Use
- No
- 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 Unsafe
- 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 |
|---|---|---|---|---|
| 40897 | Indexed-immobilization patient positioning system | A assembly of devices used primarily in radiation therapy applications, and consisting of an indexed treatment or imaging table (couch) that contains locking interfaces used to attach various positioning and immobilization devices to numbered or lettered (indexing) points on the table. It is used to ensure both adequate positioning and immobilization of a patient and to help ensure reproducible alignment between a target portion of the patient's anatomy and the radiation beams or fields used in radiation therapy treatments, diagnostic imaging studies. It may accommodate a variety of anatomically targeted patient positioning and immobilization attachments. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817355028678 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K112460 | 000 |