LOQTEQ® - LOQTEQ® Dist. Lateral Femur Plate 4.5, 7/15 - aap Implantate AG

Duns Number:328420633

Device Description: LOQTEQ® Dist. Lateral Femur Plate 4.5, 7/15 holes, L 350, R Titanium

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More Product Details

Catalog Number

PF 4510-15-2

Brand Name

LOQTEQ®

Version/Model Number

PF 4510-15-2

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

K210043

Product Code Details

Product Code

HRS

Product Code Name

Plate, Fixation, Bone

Device Record Status

Public Device Record Key

13db402e-717c-455b-ab2d-e6315e5c7a1e

Public Version Date

March 18, 2021

Public Version Number

1

DI Record Publish Date

March 10, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AAP IMPLANTATE AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 738
2 A medical device with a moderate to high risk that requires special controls. 2701