Sterile Sheath for CONVIVO

GUDID 04049539103413

Carl Zeiss Meditec AG

Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover Optical medical device procedural cover
Primary Device ID04049539103413
NIH Device Record Key15858337-3164-47ce-8d22-aa62d2403dcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterile Sheath for CONVIVO
Version Model Number302732-0530-000
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 Producttrue
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049539103413 [Primary]
GS104049539103420 [Package]
Package: [10 Units]
In Commercial Distribution
GS104049539103635 [Package]
Contains: 04049539103420
Package: [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWGEndoscope, Neurological
OWNConfocal Optical Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-23
Device Publish Date2019-12-13

Devices Manufactured by Carl Zeiss Meditec AG

04049471100143 - Treatment Pack (Size M)2024-02-19 single use accessory for ZEISS femtosecond lasers
04049471100150 - Treatment Pack (Size L)2024-02-19 single use accessory for ZEISS femtosecond lasers
04049471100167 - Treatment Pack (Type KP)2024-02-19 single use accessory for ZEISS femtosecond lasers
04049471100136 - Treatment Pack (Size S)2024-02-16 single use accessory for ZEISS femtosecond lasers
04049539101341 - EyeMag Smart2023-11-16
04049539101358 - EyeMag Pro S2023-11-16
04049539101365 - EyeMag Pro F2023-11-16
04049539064103 - PENTERO® 800 S 2023-09-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.