SCREEN COVER QUATERA 700

GUDID 04049539104717

The products are single use, sterile drapes to cover all surfaces of the main device with a potential need to get in contact with sterile objects during surgical procedures.

Carl Zeiss Meditec AG

Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use
Primary Device ID04049539104717
NIH Device Record Key65ddf08d-aee4-41ba-a1e9-be2904f2e7aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSCREEN COVER QUATERA 700
Version Model Number303061-9110-000
Company DUNS342228620
Company NameCarl Zeiss Meditec AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104049539104700 [Primary]
GS104049539104717 [Package]
Contains: 04049539104700
Package: [20 Units]
In Commercial Distribution

FDA Product Code

PUIDrape, Surgical, Exempt

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-03
Device Publish Date2022-04-25

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.