NA - K-Wire Ø1,6mm Nitinol, 550mm, blunt, 2 markings - Biedermann Motech GmbH & Co. KG

Duns Number:320249162

Device Description: K-Wire Ø1,6mm Nitinol, 550mm, blunt, 2 markings

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More Product Details

Catalog Number

212-060-0218

Brand Name

NA

Version/Model Number

212-060-0218

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

-

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

LXH

Product Code Name

ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Device Record Status

Public Device Record Key

abbbed45-f78d-4c64-9664-2094b6b300e9

Public Version Date

September 15, 2021

Public Version Number

1

DI Record Publish Date

September 07, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIEDERMANN MOTECH GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 359
2 A medical device with a moderate to high risk that requires special controls. 876