Catalog Number

-

Brand Name

miLOOP

Version/Model Number

104

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

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

HNQ

Product Code Name

Hook, Ophthalmic

Public Device Record Key

56f3ad01-82cf-4543-9a7d-54ce61383e4e

Public Version Date

June 05, 2020

Public Version Number

3

DI Record Publish Date

February 12, 2019

Package DI Number

30860000122307

Quantity per Package

6

Contains DI Package

00860000122306

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Cardboard