KOHDENT - Osteotome round PROGRESSIVE concave diameter: - Kohdent Roland Kohler Medizintechnik GmbH & Co. KG

Duns Number:324006097

Device Description: Osteotome round PROGRESSIVE concave diameter: 3,9 mm

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More Product Details

Catalog Number

3629

Brand Name

KOHDENT

Version/Model Number

3629

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

-

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

EMM

Product Code Name

CHISEL, OSTEOTOME, SURGICAL

Device Record Status

Public Device Record Key

86dc05c6-8554-491e-9b3b-d7cb42cc2eee

Public Version Date

September 07, 2021

Public Version Number

1

DI Record Publish Date

August 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KOHDENT ROLAND KOHLER MEDIZINTECHNIK GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1149