Avenue T - LDR Spine Usa, Inc.

Duns Number:615789729

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More Product Details

Catalog Number

AT990D

Brand Name

Avenue T

Version/Model Number

AT990D

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

LRP

Product Code Name

Tray, Surgical

Device Record Status

Public Device Record Key

e64ecd25-f199-409d-be02-01c5164bf362

Public Version Date

September 16, 2022

Public Version Number

7

DI Record Publish Date

December 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LDR SPINE USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 433
2 A medical device with a moderate to high risk that requires special controls. 2452
3 A medical device with high risk that requires premarket approval 61
U Unclassified 40