DEVICE: BALLOON (04953170360459)

Device Identifier (DI) Information

BALLOON
MAJ-1351
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170360459
GS1

20
711789789 *Terms of Use
No description.
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Device Characteristics

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

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ultrasound endoscope balloon, Hevea-latex A sterile balloon-like cap made of Hevea natural rubber latex (NRL) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
FDS Gastroscope and accessories, flexible/rigid
ITX Transducer, ultrasonic, diagnostic
ODG Endoscopic ultrasound system, gastroenterology-urology
EOQ BRONCHOSCOPE (FLEXIBLE OR RIGID)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042140 000
No CLOSE

Sterilization

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

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

fc26c20e-0a8c-4416-95ca-98ebdc25b8d3
July 06, 2018
3
September 21, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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

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Unit of Use DI Number: 84953170360455 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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