SINGLE USE DISTAL COVER MAJ-2315 N6192000

GUDID 14953170441278

OLYMPUS MEDICAL SYSTEMS CORP.

Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use Endoscope patient protection cap, single-use
Primary Device ID14953170441278
NIH Device Record Key5bdee026-6644-4995-b789-fd9492bfb7f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameSINGLE USE DISTAL COVER MAJ-2315
Version Model NumberMAJ-2315
Catalog NumberN6192000
Company DUNS711789789
Company NameOLYMPUS MEDICAL SYSTEMS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104953170441271 [Primary]
GS114953170441278 [Package]
Contains: 04953170441271
Package: [20 Units]
In Commercial Distribution
GS154953170441276 [Package]
Package: [60 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FDTDuodenoscope And Accessories, Flexible/Rigid
FEBAccessories, Cleaning, For Endoscope

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-09
Device Publish Date2022-06-01

Devices Manufactured by OLYMPUS MEDICAL SYSTEMS CORP.

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14953170457781 - DISPOSABLE BIOPSY FORCEPS2024-02-13
14953170457798 - DISPOSABLE BIOPSY FORCEPS2024-02-13
14953170457804 - DISPOSABLE BIOPSY FORCEPS2024-02-13
04953170457814 - DISPOSABLE BIOPSY FORCEPS2024-02-13
14953170457828 - DISPOSABLE BIOPSY FORCEPS2024-02-13

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