Absorbent Paper Points, LM-25 - Absorbent Paper Points, Length Marked 02 Taper - Meta Biomed Co., Ltd.

Duns Number:688322841

Device Description: Absorbent Paper Points, Length Marked 02 Taper 25, 200 Points, P 21

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More Product Details

Catalog Number

-

Brand Name

Absorbent Paper Points, LM-25

Version/Model Number

2869

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

-

Product Code Details

Product Code

EKN

Product Code Name

Point, Paper, Endodontic

Device Record Status

Public Device Record Key

782d5ba9-6755-44dd-973e-84874caf16d6

Public Version Date

October 03, 2022

Public Version Number

1

DI Record Publish Date

September 24, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"META BIOMED CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1335
2 A medical device with a moderate to high risk that requires special controls. 284