AVID TruCustom - AVID MEDICAL, INC.

Duns Number:015623119

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More Product Details

Catalog Number

VHWV005-13

Brand Name

AVID TruCustom

Version/Model Number

VHWV005-13_0003

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"

Yes

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

OJH

Product Code Name

Orthopedic tray

Device Record Status

Public Device Record Key

3d26eb26-7f7b-4935-a563-a93ddd76f638

Public Version Date

September 21, 2018

Public Version Number

1

DI Record Publish Date

August 21, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AVID MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5180
2 A medical device with a moderate to high risk that requires special controls. 28744