MODULIFT - MODULIFT VBR SZ.S/M BONE TAMP - AESCULAP IMPLANT SYSTEMS, LLC

Duns Number:622600992

Device Description: MODULIFT VBR SZ.S/M BONE TAMP

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More Product Details

Catalog Number

MF708R

Brand Name

MODULIFT

Version/Model Number

MF708R

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

HXG

Product Code Name

TAMP

Device Record Status

Public Device Record Key

911b2959-ea6c-48f3-bafd-8e394339e00c

Public Version Date

August 18, 2020

Public Version Number

1

DI Record Publish Date

August 10, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AESCULAP IMPLANT SYSTEMS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 200
2 A medical device with a moderate to high risk that requires special controls. 54