Primary Device ID | 07615208447071 |
NIH Device Record Key | dc8e4e1f-b358-413b-98cb-bec2e764c222 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Helioseal/Clear/F/F Plus |
Version Model Number | 558521AN |
Catalog Number | 558521AN |
Company DUNS | 448015938 |
Company Name | IVOCLAR VIVADENT AKTIENGESELLSCHAFT |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 07615208301335 [Primary] |
GS1 | 07615208447071 [Package] Contains: 07615208301335 Package: [10 Units] In Commercial Distribution |
HIBCC | DVIV558521AN1 [Previous] |
EBC | SEALANT, PIT AND FISSURE, AND CONDITIONER |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-04-14 |
Device Publish Date | 2023-04-06 |
07615208447071 | Helioseal Clear Refill 1x1.25 g |
07615208445572 | Helioseal F Plus Refill 1x1.25g |
07615208472653 | Helioseal F Plus Refill 5x1.25g |
07615208453492 | Helioseal F Plus Cavifil Refill 50x0.1g |
07615208445565 | Helioseal F Plus Refill 1x1g |