Millennium - Lumbar Spine T-Bar 25mm x 60mm TW 25mm (1"), OL - AVALIGN TECHNOLOGIES, INC.

Duns Number:792528510

Device Description: Lumbar Spine T-Bar 25mm x 60mm TW 25mm (1"), OL 71mm (2 3/4")

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More Product Details

Catalog Number

-

Brand Name

Millennium

Version/Model Number

85-63001100

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

GZT

Product Code Name

Retractor, Self-Retaining, For Neurosurgery

Device Record Status

Public Device Record Key

50c01f0c-672b-4d8f-993a-1ae16fea4985

Public Version Date

September 25, 2020

Public Version Number

1

DI Record Publish Date

September 17, 2020

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