uni® I otoscope vacuum 2.7 V, C-handle 2010

GUDID 04045396002739

The Riester otoscope has been produced with examination of the auditory canal in mind, combined with a Riester ear speculum.

Rudolf Riester GmbH

Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct Otoscope, direct
Primary Device ID04045396002739
NIH Device Record Keyd6c5c120-1522-4062-b360-238dfa5c6390
Commercial Distribution StatusIn Commercial Distribution
Brand Nameuni® I otoscope vacuum 2.7 V, C-handle
Version Model Number2010
Catalog Number2010
Company DUNS537208717
Company NameRudolf Riester GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]
GS104045396002739 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope
ERAOtoscope

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

Devices Manufactured by Rudolf Riester GmbH

04045396002739 - uni® I otoscope vacuum 2.7 V, C-handle2021-01-13The Riester otoscope has been produced with examination of the auditory canal in mind, combined with a Riester ear speculum.
04045396002739 - uni® I otoscope vacuum 2.7 V, C-handle2021-01-13 The Riester otoscope has been produced with examination of the auditory canal in mind, combined with a Riester ear speculum.
04045396155374 - ri-champion® N, Pull through strap velcro cuff adult size, latex free2019-11-08 ri-champion® N is a non-invasive blood pressure monitors for measuring at the upper arm
04045396201231 - ri-medic, tabletop, adult cuff and adult cuff obese, latex free2019-11-08 The ri-medic NIBP device is designed for the measurement and display of systolic and diastolic blood pressure and pulse rate.
04045396201248 - ri-medic Bluetooth®, tabletop, adult cuff and adult cuff obese, latex free2019-11-08 The ri-medic NIBP device is designed for the measurement and display of systolic and diastolic blood pressure and pulse rate.
04045396201255 - ri-medic, mobile version, adult cuff and adult cuff obese, latex free2019-11-08 The ri-medic NIBP device is designed for the measurement and display of systolic and diastolic blood pressure and pulse rate.
04045396201262 - ri-medic Bluetooth®, mobile version, adult cuff an adult cuff obese, latex free2019-11-08 The ri-medic NIBP device is designed for the measurement and display of systolic and diastolic blood pressure and pulse rate.
04045396201279 - ri-medic, wall mount, adult cuff and adult cuff obese, latex free2019-11-08 The ri-medic NIBP device is designed for the measurement and display of systolic and diastolic blood pressure and pulse rate.
04045396201286 - ri-medic, Bluetooth®, wall mount, adult cuff and adult cuff obese, latex free2019-11-08 The ri-medic NIBP device is designed for the measurement and display of systolic and diastolic blood pressure and pulse rate.

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.