Olympus - Sealing cap, blue, for Luer-lock, 6 pcs. - OLYMPUS Winter & Ibe GmbH

Duns Number:316957240

Device Description: Sealing cap, blue, for Luer-lock, 6 pcs.

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More Product Details

Catalog Number

A0400

Brand Name

Olympus

Version/Model Number

A0400

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code Details

Product Code

FGA

Product Code Name

Kit, Nephroscope

Device Record Status

Public Device Record Key

7754019b-8910-44b7-9a46-6c30621b292e

Public Version Date

October 08, 2018

Public Version Number

3

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 WINTER & IBE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 1109