Catalog Number

345-342

Brand Name

SONTEC GLABELLA RASP

Version/Model Number

345-342

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

KBA

Product Code Name

RASP, NASAL

Public Device Record Key

c6f33244-6b58-4951-aeeb-1eb3af9aeea5

Public Version Date

December 07, 2018

Public Version Number

2

DI Record Publish Date

September 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-