JBP Nanoneedle - Feeltech Co.,Ltd.

Duns Number:688432407

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More Product Details

Catalog Number

-

Brand Name

JBP Nanoneedle

Version/Model Number

JBP Nanoneedle 23Gx13mm

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K092831,K092831,K092831,K092831

Product Code Details

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

faab3f15-d6f9-4c45-8b3e-843d43ebd320

Public Version Date

October 23, 2019

Public Version Number

5

DI Record Publish Date

October 23, 2017

Additional Identifiers

Package DI Number

38809407781665

Quantity per Package

4000

Contains DI Package

28809407781668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FEELTECH CO.,LTD." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2