TKMD - The TK Sterile Hypodermic Needle is intended for - Anhui Tiankang Medical Technology Co., Ltd.

Duns Number:527035248

Device Description: The TK Sterile Hypodermic Needle is intended for use with syringes and injection devices f The TK Sterile Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

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More Product Details

Catalog Number

-

Brand Name

TKMD

Version/Model Number

TKHN

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"

Yes

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

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Device Record Status

Public Device Record Key

52af93a3-1693-4ed7-9bc6-d4944b5cd8fa

Public Version Date

February 18, 2021

Public Version Number

2

DI Record Publish Date

February 05, 2021

Additional Identifiers

Package DI Number

16934841580456

Quantity per Package

100

Contains DI Package

06934841580459

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"ANHUI TIANKANG MEDICAL TECHNOLOGY 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. 1