Mitaka MM51 cover

GUDID 17290115960164

Operating room microscope cover

PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.

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Primary Device ID17290115960164
NIH Device Record Key80e2d4ab-5b99-4b85-9116-a4fcb7cf20cb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMitaka MM51 cover
Version Model Number80-573H
Company DUNS532186541
Company NamePHARMA SEPT MEDICAL PRODUCTS (1995) LTD.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290115960167 [Primary]
GS117290115960164 [Package]
Contains: 07290115960167
Package: box [10 Units]
In Commercial Distribution
GS127290115960161 [Package]
Package: box [3 Units]
In Commercial Distribution

FDA Product Code

HRMMicroscope, Operating & Accessories, Ac-Powered, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-21
Device Publish Date2022-11-13

Devices Manufactured by PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.

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01836230000768 - Microscope Cover ZEISS "MD" 115/260 6.502022-11-28 Medical equipment drape, single-use
01836230002007 - C-Arm Cover UNIVERSAL 112/1832022-11-28 Medical equipment drape, single-use
01836230002014 - C-Arm Cover IMAGE INTENSHFIER 115/2402022-11-28 Medical equipment drape, single-use
01836230002052 - C-Arm Cover 152/2652022-11-28 Medical equipment drape, single-use
01836230002120 - Mini C-Arm Cover & X-Ray Drape 138/1602022-11-28 Medical equipment drape, single-use
01836230004124 - X-Ray Cassette Cover2022-11-28 Medical equipment drape, single-use

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