Tecomet - Extractor Assembly, 1.5mm Conic Screw - TECOMET INC.

Duns Number:078749695

Device Description: Extractor Assembly, 1.5mm Conic Screw

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More Product Details

Catalog Number

-

Brand Name

Tecomet

Version/Model Number

RS101014

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 03, 2022

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

HWB

Product Code Name

Extractor

Device Record Status

Public Device Record Key

8501b77d-2b71-4917-bccc-4f5b8e25daf9

Public Version Date

October 04, 2022

Public Version Number

2

DI Record Publish Date

October 09, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TECOMET INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1505
2 A medical device with a moderate to high risk that requires special controls. 9
3 A medical device with high risk that requires premarket approval 1