PROTECTION TUBE - MAJ-1222 PROTECTION TUBE FOR LTF-160 - OLYMPUS MEDICAL SYSTEMS CORP.

Duns Number:711789789

Device Description: MAJ-1222 PROTECTION TUBE FOR LTF-160

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More Product Details

Catalog Number

-

Brand Name

PROTECTION TUBE

Version/Model Number

MAJ-1222

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 09, 2022

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K942338

Product Code Details

Product Code

FDT

Product Code Name

duodenoscope and accessories, flexible/rigid

Device Record Status

Public Device Record Key

e79789ed-67ca-4dea-b214-82a74c24ccbc

Public Version Date

August 10, 2022

Public Version Number

6

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"OLYMPUS MEDICAL SYSTEMS CORP." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 117
2 A medical device with a moderate to high risk that requires special controls. 1962
U Unclassified 52