Pilling - GAR DENT TEETH GUARDS 3 PAIR/BOX - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: GAR DENT TEETH GUARDS 3 PAIR/BOX

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More Product Details

Catalog Number

502276

Brand Name

Pilling

Version/Model Number

IPN007744

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

-

Product Code Details

Product Code

KBN

Product Code Name

GAG, MOUTH

Device Record Status

Public Device Record Key

af66b247-f9da-4c9a-98a3-7c85acc2d5c7

Public Version Date

October 16, 2018

Public Version Number

1

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

44026704600333

Quantity per Package

3

Contains DI Package

24026704600339

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26