LIGAPASS - LIGAPASS 2.0 DUAL BAND - MEDICREA INTERNATIONAL

Duns Number:383228632

Device Description: LIGAPASS 2.0 DUAL BAND

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More Product Details

Catalog Number

-

Brand Name

LIGAPASS

Version/Model Number

B08100010

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

K132395

Product Code Details

Product Code

OWI

Product Code Name

Bone Fixation Cerclage, Sublaminar

Device Record Status

Public Device Record Key

211f9d87-671a-475f-ab05-11ae74194049

Public Version Date

May 23, 2022

Public Version Number

5

DI Record Publish Date

October 23, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICREA INTERNATIONAL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1328
2 A medical device with a moderate to high risk that requires special controls. 3995