Catalog Number

-

Brand Name

Hive-C IBFD

Version/Model Number

C-C-0003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K180364

Product Code

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Public Device Record Key

f5c5b8b2-f024-43b6-9ccd-42a8aa488d4b

Public Version Date

October 19, 2021

Public Version Number

5

DI Record Publish Date

August 07, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-