DEVICE: SINGLE USE BIOPSY VALVE (Sterile) (14953170247573)

Device Identifier (DI) Information

SINGLE USE BIOPSY VALVE (Sterile)
MAJ-1555
In Commercial Distribution
N3043000
OLYMPUS MEDICAL SYSTEMS CORP.
14953170247573
GS1

20
711789789 *Terms of Use
Disposable biopsy valve MAJ-1555
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
62145 Endoscope working-channel valve, single-use
A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
FDF Colonoscope And Accessories, Flexible/Rigid
FDS Gastroscope And Accessories, Flexible/Rigid
NWB Endoscope, Accessories, Narrow Band Spectrum
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

ceaa3256-b6ba-461d-ac5a-f206345d5b19
July 25, 2024
9
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
54953170247571 60 14953170247573 2023-09-19 Not in Commercial Distribution
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 04953170247576 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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