Catalog Number

1110301

Brand Name

PureLife Dental

Version/Model Number

1110301

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

Yes

For Single-Use

Yes

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

NAC

Product Code Name

Dressing, Wound, Hydrophilic

Public Device Record Key

a294aa44-3ea0-4a4f-9ee7-4691911565e6

Public Version Date

June 11, 2020

Public Version Number

2

DI Record Publish Date

May 13, 2020

Package DI Number

D79011103013

Quantity per Package

5000

Contains DI Package

D79011103011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case