Primary Device ID | EDEL61710W0 |
NIH Device Record Key | c790bf70-b749-41dd-87c6-812c008db3ec |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | COSMESEAL™ Filled |
Version Model Number | 61710W |
Catalog Number | 61710W |
Company DUNS | 344805101 |
Company Name | DeltaMed GmbH |
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 | true |
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 |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Special Storage Condition, Specify | Between 0 and 0 *avoid direct sunlight |
Storage Environment Temperature | Between 4 Degrees Celsius and 24 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D77961710W0 [Previous] |
HIBCC | EDEL61710W0 [Primary] |
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 | 2023-06-13 |
Device Publish Date | 2023-06-05 |
EDEL16110100 - 3Delta Etemp | 2023-09-25 3Delta Etemp A1, 1000g |
EDEL16110200 - 3Delta Etemp | 2023-09-25 3Delta Etemp A2, 1000g |
EDEL16110300 - 3Delta Etemp | 2023-09-25 3Delta Etemp A3, 1000g |
EDEL3011OP0 - Renamel® Flowable Microfill | 2023-09-22 Renamel® Flowable Microfill OPAL™, Syringe 3g |
EDEL6071OP0 - Renamel® Microfill | 2023-09-22 Renamel® Microfill OPALITE™, Syringe 4g |
EDEL13700100 - DELTASPLINT | 2023-07-07 DELTASPLINT, 12 Rods |
EDEL13700200 - DELTABOND | 2023-07-07 DELTABOND, Bottle 10ml |
EDEL13700300 - DELTAGLACE | 2023-07-07 DELTAGLACE, Bottle 10ml |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
COSMESEAL 78462776 3099189 Live/Registered |
Cosmedent, Inc. 2004-08-05 |