n/a - Tibial Cone Keel Template Sz 2 - Ortho Development Corporation

Duns Number:876542390

Device Description: Tibial Cone Keel Template Sz 2

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More Product Details

Catalog Number

-

Brand Name

n/a

Version/Model Number

662-7002

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K182085

Product Code Details

Product Code

JWY

Product Code Name

Manual antimicrobial susceptibility test systems

Device Record Status

Public Device Record Key

87e4a2bb-12ec-4ff4-a3ab-3cb7e2f4ae22

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

October 30, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ORTHO DEVELOPMENT CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3694
2 A medical device with a moderate to high risk that requires special controls. 3650