Primary Device ID | E241AA3431 |
NIH Device Record Key | b8da70de-b21e-4300-9a52-15d7d6ac4458 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Cavex ColorChange |
Version Model Number | AA343 |
Catalog Number | AA343 |
Company DUNS | 419980156 |
Company Name | Cavex Holland B.V. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +31(0)235307700 |
r.woortman@cavex.nl |
Weight | 5.4 Kilogram |
Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E241AA3431 [Primary] |
ELW | Material, Impression |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-06-09 |
E241AA3431 | Dental Alginate Impression material |
E241AA3430 | Dental Alginate Impression material |
E241AA3231 | Dental Alginate Impression material |
E241AA3230 | Dental Alginate Impression material |