FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Cavex ImpreSafe container
DI: E241HT0200
·
Model: HT020
·
Cavex Holland B.V.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Cavex ImpreSafe container
- Primary DI
- E241HT0200
- Version / Model
- HT020
- Catalog Number
- HT020
- Company Name
- Cavex Holland B.V.
- Labeler DUNS
- 419980156
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-07-07
- Public Version
- 4
- Public Version Date
- 2026-03-05
- Public Version Status
- Update
- Public Device Record Key
- 48bad82a-5ec8-4df8-ba45-be2cac7135c2
- Distribution End Date
- 2026-03-04
Device Description
Dental impression disinfectant
Device Characteristics
- Single Use
- No
- 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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- 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 |
|---|---|---|---|---|
| LRJ | Disinfectant, Medical Devices | General Hospital | 880.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35871 | Denture cleanser | An agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. 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 | E241HT0200 | HIBCC |
Customer Contacts
- Phone
- +31(0)235307700
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 1 pcs |