SACRONAIL - DescriptionThe SACRONAIL system provides a - SIGNUS Medizintechnik GmbH

Duns Number:344203948

Device Description: DescriptionThe SACRONAIL system provides a sustained, stable restoration of dorsal pelvic

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More Product Details

Catalog Number

PBX080194

Brand Name

SACRONAIL

Version/Model Number

Pelvic nail

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

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

K212755

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

9f1b2be2-6672-4669-8497-591175c7ea30

Public Version Date

March 25, 2022

Public Version Number

1

DI Record Publish Date

March 17, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SIGNUS MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 522
2 A medical device with a moderate to high risk that requires special controls. 1837