Primary Device ID | EDMG9997658 |
NIH Device Record Key | 78df8e94-375d-4348-a40d-949c376b3530 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | O-Bite |
Version Model Number | 999765 |
Catalog Number | 999765 |
Company DUNS | 320744915 |
Company Name | DMG Chemisch-Pharmazeutische Fabrik 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 | false |
Lot Batch | true |
Serial Number | true |
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 | 201-894-5505 |
eanagnostos@dmg-america.com |
Storage Environment Temperature | Between 59 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
HIBCC | EDMG9997650 [Primary] |
HIBCC | EDMG9997651 [Package] Contains: EDMG9997650 Package: [4 Units] In Commercial Distribution |
HIBCC | EDMG9997658 [Package] Contains: EDMG9997651 Package: [6 Units] In Commercial Distribution |
ELW | Material, Impression |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2016-09-22 |
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Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() O-BITE 78425578 3080628 Live/Registered |
Muhlbauer Technology GmbH 2004-05-26 |