Primary Device ID | E23929561 |
NIH Device Record Key | 935cc3a1-54fb-48e5-a465-7c25e0ef73f9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Otoform® A softX |
Version Model Number | 2956 |
Catalog Number | 2956 |
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 |
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 | E23929561 [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 | 2022-08-22 |
Device Publish Date | 2022-08-12 |
E2398801M1 | No. |
E23988011 | No. |
E23929561 | No. |
E23988021 | No. |
E2398802M1 | No. |
E2398802ST1 | No. |
E2398802AU1 | No. |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() OTOFORM 79212229 5383052 Live/Registered |
Dreve Otoplastik GmbH 2017-05-18 |