DEVICE: Biopsy valve (04953170063947)
Device Identifier (DI) Information
Biopsy valve
MB-358
In Commercial Distribution
GX0283
OLYMPUS MEDICAL SYSTEMS CORP.
MB-358
In Commercial Distribution
GX0283
OLYMPUS MEDICAL SYSTEMS CORP.
"MB-358 SEMI-DISPOSABLE BIOPSY VALVE"
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
64366 | Endoscopic biopsy valve, reusable |
A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FDS | Gastroscope And Accessories, Flexible/Rigid |
FDF | Colonoscope And Accessories, Flexible/Rigid |
NWB | Endoscope, Accessories, Narrow Band Spectrum |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
---|
High-level Disinfectant |
Ethylene Oxide |
Moist Heat or Steam Sterilization |
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8e275f05-c817-4a50-b8b8-8f6ff1359e2a
December 25, 2023
9
September 21, 2016
December 25, 2023
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
84953170063943
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)401-1086
xx@xx.xx
xx@xx.xx