RESCAN 700

GUDID 04049539072108

Carl Zeiss Meditec AG

Spectral-domain optical coherence tomography system
Primary Device ID04049539072108
NIH Device Record Keyfba18458-74e2-4d7e-a115-55500f3da965
Commercial Distribution StatusIn Commercial Distribution
Brand NameRESCAN 700
Version Model Number7210
Company DUNS342228620
Company NameCarl Zeiss Meditec AG
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 Batchfalse
Serial Numbertrue
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
GS104049539072108 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OBOTomography, Optical Coherence

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by Carl Zeiss Meditec AG

04049539064080 - INTRABEAM2025-04-09 The INTRABEAM 700 is a medical device used in the context of Radiation Therapy. It is used unsterile given that it shall be pla
04049539066503 - INTRABEAM SMART Stand2025-04-09 The INTRABEAM SMART Stand is connected to the INTRABEAM 700 (Workplace). The INTABEAM SMART Stand shall be used to mount the X-
04049539066435 - TIVATO® 7002025-01-30
04049539106018 - SMARTDRAPE2025-01-30
04049539106070 - INTRABEAM SMARTDRAPE2025-01-30
04049539106094 - SMARTDRAPE2025-01-30
04049539106889 - EyeMag Smart TTL2025-01-30
04049539106896 - EyeMag Classic2025-01-30

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.