Invictus - Distractor Tip, Lamina, Short, Right - ALPHATEC SPINE, INC.

Duns Number:602465783

Device Description: Distractor Tip, Lamina, Short, Right

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More Product Details

Catalog Number

-

Brand Name

Invictus

Version/Model Number

17447-R

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

HTD

Product Code Name

FORCEPS

Device Record Status

Public Device Record Key

d1934896-e9b8-4eab-af9a-6d47c754997b

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALPHATEC SPINE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5644
2 A medical device with a moderate to high risk that requires special controls. 26570
U Unclassified 15