LTJ - LTJ 3.75mm Solid Ti Screw L. 32mm Non Sterile - AzurMeds Inc.

Duns Number:117700483

Device Description: LTJ 3.75mm Solid Ti Screw L. 32mm Non Sterile

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More Product Details

Catalog Number

-

Brand Name

LTJ

Version/Model Number

81004162333

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

K210268

Product Code Details

Product Code

HWC

Product Code Name

Screw, Fixation, Bone

Device Record Status

Public Device Record Key

4ec3410c-ee7c-4dd7-99fe-bc491d30618b

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

May 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AZURMEDS INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 27
2 A medical device with a moderate to high risk that requires special controls. 42