CONELOG® PROGRESSIVE-LINE Implant, Promote® plus - CONELOG® PROGRESSIVE-LINE Implant, Promote® plus, - ALTATEC GmbH

Duns Number:322018193

Device Description: CONELOG® PROGRESSIVE-LINE Implant, Promote® plus, d 3.8 mm, L 13 mm

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More Product Details

Catalog Number

C1086.3813

Brand Name

CONELOG® PROGRESSIVE-LINE Implant, Promote® plus

Version/Model Number

C1086.3813

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

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

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

ad09eada-e57f-461d-90dd-697f53ce9723

Public Version Date

October 22, 2020

Public Version Number

1

DI Record Publish Date

October 14, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALTATEC GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 290
2 A medical device with a moderate to high risk that requires special controls. 901