FDA UDI
In Commercial Distribution
🇺🇸 United States
CavaClear
DI: 00813132022976
·
Model: 500-516
·
Philips Image Guided Therapy Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CavaClear
- Primary DI
- 00813132022976
- Version / Model
- 500-516
- Catalog Number
- 500-516
- Company Name
- Philips Image Guided Therapy Corporation
- Labeler DUNS
- 118354223
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-03
- Public Version
- 1
- Public Version Date
- 2022-03-11
- Public Version Status
- New
- Public Device Record Key
- a28d566f-799b-4d95-b3df-9ae934b85664
Device Description
16F CavaClear Laser Sheath
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| QRJ | Laser-Powered Inferior Vena Cava Filter Retrieval Catheter | Cardiovascular | 870.5125 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45162 | Vena cava filter extraction/repositioning kit | A collection of sterile devices designed to perform the percutaneous retrieval or repositioning of an implanted inferior vena cava (IVC) filter. It will typically contain various dedicated catheters with dilating, pushing, and retrieval functions (e.g., gripping claws, loop/lasso) and devices such as needles and guide wires. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00813132022976 | GS1 |
Customer Contacts
- Phone
- 1-800-231-0978
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| DEN210024 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry; Keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- – 140 Degrees Fahrenheit