NA - 5.5 ROD, MIS, LORDOTIC, Ti6Al4VELI - HYHTE HOLDINGS, INC.

Duns Number:073029645

Device Description: 5.5 ROD, MIS, LORDOTIC, Ti6Al4VELI

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More Product Details

Catalog Number

ACJA55025

Brand Name

NA

Version/Model Number

ACJA55025

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

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

KWP

Product Code Name

Appliance, Fixation, Spinal Interlaminal

Device Record Status

Public Device Record Key

669ad0b0-c3ed-432a-a85a-3e85d7e1efa3

Public Version Date

June 09, 2021

Public Version Number

1

DI Record Publish Date

June 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HYHTE HOLDINGS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 80
2 A medical device with a moderate to high risk that requires special controls. 12769