IdentiTi - CERVICAL SA VARIABLE ANGLE DRIVER, LONG, TAPERED - ALPHATEC SPINE, INC.

Duns Number:602465783

Device Description: CERVICAL SA VARIABLE ANGLE DRIVER, LONG, TAPERED

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More Product Details

Catalog Number

-

Brand Name

IdentiTi

Version/Model Number

135-2310

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

HXX

Product Code Name

SCREWDRIVER

Device Record Status

Public Device Record Key

ab56eb95-9413-46e6-b62e-821ae0849ea7

Public Version Date

December 13, 2021

Public Version Number

1

DI Record Publish Date

December 05, 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