Image Cover 36R

GUDID 00836230004002

Medical equipment handle cover, single-use, sterile

PHARMA SEPT MEDICAL PRODUCTS (1995) LTD.

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Primary Device ID00836230004002
NIH Device Record Key494d0111-0626-4c5b-b841-23224cf5675f
Commercial Distribution StatusIn Commercial Distribution
Brand NameImage Cover 36R
Version Model Number5002
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
GS100836230004002 [Primary]
GS101836230004001 [Package]
Package: [15 Units]
In Commercial Distribution
GS102836230004000 [Package]
Contains: 01836230004001
Package: [4 Units]
In Commercial Distribution

FDA Product Code

KQMCamera, Surgical And Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-23
Device Publish Date2022-11-15

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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