Millennium - Cobb Elevator he hdl - AVALIGN TECHNOLOGIES, INC.

Duns Number:792528510

Device Description: Cobb Elevator he hdl

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More Product Details

Catalog Number

-

Brand Name

Millennium

Version/Model Number

1-57101013

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

GEG

Product Code Name

ELEVATOR, SURGICAL, GENERAL & PLASTIC SURGERY

Device Record Status

Public Device Record Key

4b94986c-39f1-4660-9eb5-d8e7a1223cb2

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

November 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVALIGN TECHNOLOGIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6832
2 A medical device with a moderate to high risk that requires special controls. 9482