Catalog Number

27824

Brand Name

REGO HUB,RAULAND R5,1.5FT-C,2FT-P

Version/Model Number

HB01-900000010M2

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

ILQ

Product Code Name

System, Communication, Powered

Public Device Record Key

cb1272b1-0d10-40c3-9d9c-5bf22ac706f2

Public Version Date

July 14, 2022

Public Version Number

1

DI Record Publish Date

July 06, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-