DEVICE: SINGLE USE BIOPSY VALVE (Sterile) (14953170152433)
Device Identifier (DI) Information
SINGLE USE BIOPSY VALVE (Sterile)
MAJ-210
In Commercial Distribution
GL2167
OLYMPUS MEDICAL SYSTEMS CORP.
MAJ-210
In Commercial Distribution
GL2167
OLYMPUS MEDICAL SYSTEMS CORP.
SINGLE USE BIOPSY VALVE MAJ-210
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EOB | Nasopharyngoscope (Flexible Or Rigid) |
EOQ | Bronchoscope (Flexible Or Rigid) |
NWB | Endoscope, Accessories, Narrow Band Spectrum |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
387718f4-50f4-41b0-a129-211462cf1503
July 25, 2024
9
September 21, 2016
July 25, 2024
9
September 21, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
54953170152431 | 70 | 14953170152433 | 2023-09-19 | Not in Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
04953170152436
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)401-1086
xx@xx.xx
xx@xx.xx