Medicon - Ti Sternal Fixation screw lock 2.4x12mm - Medicon eG. Chirurgiemechaniker-Genossenschaft

Duns Number:315492330

Device Description: Ti Sternal Fixation screw lock 2.4x12mm self-drill purp P/10

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More Product Details

Catalog Number

54.80.12

Brand Name

Medicon

Version/Model Number

54.80.12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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)

-

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

HRS

Product Code Name

Plate, fixation, bone

Device Record Status

Public Device Record Key

fdd366e6-37e8-4ab3-95bc-79757e92da67

Public Version Date

October 29, 2021

Public Version Number

1

DI Record Publish Date

October 21, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICON EG. CHIRURGIEMECHANIKER-GENOSSENSCHAFT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7911
2 A medical device with a moderate to high risk that requires special controls. 1064