DEVICE: Olympus (04953170355981)

Device Identifier (DI) Information

Olympus
MAJ-1352
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170355981
GS1

1
711789789 *Terms of Use
MAJ-1352 BALLOON APP. FOR EBUS BRONCHSCP
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
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.
CLOSE

FDA Product Code

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

FDA Premarket Submission

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

Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization
High-level Disinfectant
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

6c2814bb-c1d5-4d59-97d7-de74d1354707
October 08, 2018
4
September 21, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

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