FDA UDI
In Commercial Distribution
🇺🇸 United States
VisCalor bulk
DI: E22160621
·
Model: 6062
·
VOCO GmbH
Product Codes
2
GMDN Terms
2
Identifiers
2
Pkg Device Count
80
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Basic Information
- Brand Name
- VisCalor bulk
- Primary DI
- E22160621
- Version / Model
- 6062
- Company Name
- VOCO GmbH
- Labeler DUNS
- 316699578
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 80
- Record Status
- Published
- Publish Date
- 2019-05-10
- Public Version
- 1
- Public Version Date
- 2019-05-20
- Public Version Status
- New
- Public Device Record Key
- 78c3098d-2a41-4d0f-8eb3-c56de436d892
Device Description
set contains Caps Sticks A1, A2, A3, uni, VisCalor Dispenser
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| EEG | Heat Source For Bleaching Teeth | Dental | 872.6475 | 1 |
| EBF | Material, Tooth Shade, Resin | Dental | 872.3690 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31810 | Anaesthesia warmer | A mains electricity (AC-powered) heating device into which tubes containing anaesthetic solutions are placed intended to warm the solution prior to it being administered to a patient for anaesthesia. It typically consists of a tabletop device that has wells for the anaesthetic solution tubes, a heating element, a thermostat and operating controls. It is designed to be portable for use in different locations where anaesthesia is administered. | No | Active |
| 35870 | Dental composite resin | A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E22160621 | HIBCC | ||||
| Unit of Use | E2216062 | HIBCC |
Customer Contacts
- Phone
- 999-999-9999
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 23 Degrees Celsius