Microscope Cover LEICA 115/210 W/DRAWSTRING HLT

GUDID 01836230005008

Medical equipment drape, single-use

PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.

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Primary Device ID01836230005008
NIH Device Record Keydaeccf81-29b2-40bb-8172-68eb887471e5
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicroscope Cover LEICA 115/210 W/DRAWSTRING HLT
Version Model Number9216DS
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
GS100836230005009 [Primary]
GS101836230005008 [Package]
Contains: 00836230005009
Package: box [5 Units]
In Commercial Distribution
GS102836230005007 [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

On-Brand Devices [Microscope Cover LEICA 115/210 W/DRAWSTRING HLT]

01836230005008Medical equipment drape, single-use
01836230000997Medical equipment drape, single-use

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