Microscope Cover LEICA 115/300 10.50

GUDID 01836230000386

Medical equipment drape, single-use

PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.

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Primary Device ID01836230000386
NIH Device Record Key4fa3f3f6-0b31-4e2d-8084-2985f8637924
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroscope Cover LEICA 115/300 10.50
Version Model Number8235
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
GS100836230000387 [Primary]
GS101836230000386 [Package]
Contains: 00836230000387
Package: box [5 Units]
In Commercial Distribution
GS102836230000385 [Package]
Package: box [4 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 Date2022-11-24
Device Publish Date2022-11-16

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

01836230000737 - MS DRAPE For Zeiss W/HLT ANGLE LENS 45”x118”, 115x300cm2022-11-28 Medical equipment drape, single-use
01836230000744 - Microscope Cover ZEISS 137/380 6.50 HLT2022-11-28 Medical equipment drape, single-use
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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