Tecomet - LAMBOTTE OSTEOTOME 9" STRAIGHT 1/2" - TECOMET INC.

Duns Number:078749695

Device Description: LAMBOTTE OSTEOTOME 9" STRAIGHT 1/2"

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More Product Details

Catalog Number

-

Brand Name

Tecomet

Version/Model Number

46306

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

-

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

GFI

Product Code Name

Osteotome, Manual

Device Record Status

Public Device Record Key

05f2fe86-3a5a-4d63-ab76-7e4e9599e7f7

Public Version Date

October 23, 2020

Public Version Number

1

DI Record Publish Date

October 15, 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