Pointer Endoscopic Marker - OSTEONIC CO.,Ltd.

Duns Number:688999370

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More Product Details

Catalog Number

-

Brand Name

Pointer Endoscopic Marker

Version/Model Number

OSP-100

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

Yes

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

NBG

Product Code Name

Marker,Colon

Device Record Status

Public Device Record Key

d854563c-10c4-4dce-a2e8-fd1646841053

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

May 12, 2017

Additional Identifiers

Package DI Number

08809539692579

Quantity per Package

20

Contains DI Package

08809539692562

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"OSTEONIC CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 26
2 A medical device with a moderate to high risk that requires special controls. 218