Catalog Number

89-2718K

Brand Name

PILLING

Version/Model Number

IPN010269

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

FDG

Product Code Name

RETRACTOR, FIBEROPTIC

Public Device Record Key

818efb34-7729-4bec-b2e6-efa35159e599

Public Version Date

October 16, 2018

Public Version Number

1

DI Record Publish Date

September 15, 2018

Package DI Number

34026704411048

Quantity per Package

6

Contains DI Package

24026704411041

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box