FDA UDI
In Commercial Distribution
🇺🇸 United States
VALO™ Barrier Sleeves
DI: 07350069421845
·
Model: VALO X 600 Barrier Sleeves Refill
·
Minitube AB
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
300
Basic Information
- Brand Name
- VALO™ Barrier Sleeves
- Primary DI
- 07350069421845
- Version / Model
- VALO X 600 Barrier Sleeves Refill
- Catalog Number
- 5898
- Company Name
- Minitube AB
- Labeler DUNS
- 775295061
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 300
- Record Status
- Published
- Publish Date
- 2024-05-01
- Public Version
- 3
- Public Version Date
- 2024-09-11
- Public Version Status
- Update
- Public Device Record Key
- 2457bd1d-6484-4382-a555-e86181c91360
Device Description
Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient's tissues, as well as etchants and other chemistry, and are highly important for keeping your VALO curing light sanitary. Barrier sleeves are available in three sizes to fit VALO™ X, VALO™ Grand, and VALO™ Corded/Cordless curing lights. Prevents direct contact between your VALO curing light and the patient’s tissues Protects your VALO curing light from direct contact with etchants and other chemistry Important for maintaining sanitary conditions Available in three sizes
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| PEM | Dental Barriers And Sleeves | General, Plastic Surgery | 878.4370 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12535 | Medical equipment/instrument drape, single-use | A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 07350069422842 | GS1 | Wrapped bundle | 2 | In Commercial Distribution | |
| Primary | 07350069421845 | GS1 | ||||
| Unit of Use | 07350069420848 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K211026 | 000 |