EMERGE Micro Anterior Cervical Plate System - DTS DRILL 10mm - Evolution Spine LLC

Duns Number:116940934

Device Description: DTS DRILL 10mm

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More Product Details

Catalog Number

101-A011

Brand Name

EMERGE Micro Anterior Cervical Plate System

Version/Model Number

101-A011

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

-

Product Code Details

Product Code

LXH

Product Code Name

Orthopedic manual surgical instrument

Device Record Status

Public Device Record Key

be1c17d1-c0eb-4dec-8406-e063762a9541

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 10, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EVOLUTION SPINE LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 485
2 A medical device with a moderate to high risk that requires special controls. 1141