PureForm - "5PN01* PureForm Para-Nasal - Medium Left" - SURGICAL TECHNOLOGY LABORATORIES INC

Duns Number:080380106

Device Description: "5PN01* PureForm Para-Nasal - Medium Left"

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More Product Details

Catalog Number

5PN01*

Brand Name

PureForm

Version/Model Number

5PN01*

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K091011

Product Code Details

Product Code

FZE

Product Code Name

Prosthesis, Nose, Internal

Device Record Status

Public Device Record Key

fb702a35-97b7-4084-84d3-716963a55af7

Public Version Date

September 07, 2021

Public Version Number

1

DI Record Publish Date

August 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SURGICAL TECHNOLOGY LABORATORIES INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 209