Millennium - Turner Warwick Adult Retr Set SS Set - AVALIGN TECHNOLOGIES, INC.

Duns Number:792528510

Device Description: Turner Warwick Adult Retr Set SS Set

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More Product Details

Catalog Number

-

Brand Name

Millennium

Version/Model Number

63-GU8262

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

FFO

Product Code Name

RETRACTOR, SELF-RETAINING

Device Record Status

Public Device Record Key

a064506f-d294-4f18-a07c-8181394a92b7

Public Version Date

November 10, 2021

Public Version Number

1

DI Record Publish Date

November 02, 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