Catalog Number

TLB01

Brand Name

HARMONIC

Version/Model Number

TLB01

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

-

Product Code

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Public Device Record Key

76e746d0-c29e-4480-b9cf-ec9c5c1e1b2e

Public Version Date

October 16, 2019

Public Version Number

3

DI Record Publish Date

July 15, 2016

Package DI Number

30705036003117

Quantity per Package

50

Contains DI Package

10705036003113

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE