LOCATOR - Guided Surgical Tray Assembly - Zest Anchors, LLC

Duns Number:078387192

Device Description: Guided Surgical Tray Assembly

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More Product Details

Catalog Number

-

Brand Name

LOCATOR

Version/Model Number

07993

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

NDP

Product Code Name

Accessories, implant, dental, endosseous

Device Record Status

Public Device Record Key

52597e9e-d91d-4df4-adc3-cbe0c9308ade

Public Version Date

July 15, 2022

Public Version Number

1

DI Record Publish Date

July 07, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZEST ANCHORS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 398
2 A medical device with a moderate to high risk that requires special controls. 2802