Primary Device ID | E2397431 |
NIH Device Record Key | b9dc5279-0d31-4a98-bffc-29d2be821581 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Precise II |
Version Model Number | 743 |
Catalog Number | 743 |
Company DUNS | 315808340 |
Company Name | Dreve Otoplastik GmbH |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de | |
Phone | +49230388070 |
otoplastik@dreve.de |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Storage Environment Temperature | Between 18 Degrees Celsius and 28 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E2397431 [Primary] |
LDG | Kit, earmold, impression |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-12-13 |
Device Publish Date | 2022-12-05 |
E23905651 - Otoferm® Creme | 2024-07-03 No. |
E239282081 - Biopor® AB | 2024-05-16 No. |
E23928208M1 - Biopor® AB | 2024-05-16 No. |
E239282091 - Biopor® AB | 2024-05-16 No. |
E23928209M1 - Biopor® AB | 2024-05-16 No. |
E239282141 - Biopor® AB | 2024-05-16 No. |
E23928214M1 - Biopor® AB | 2024-05-16 No. |
E239282161 - Biopor® AB | 2024-05-16 No. |