Clinpro™ - 3M™ ESPE™ Clinpro™ Sealant & Adper™ Prompt™ - 3M COMPANY

Duns Number:830016148

Device Description: 3M™ ESPE™ Clinpro™ Sealant & Adper™ Prompt™ L-Pop™ Self-Etch Adhesive Trial Kit, 12626TP

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More Product Details

Catalog Number

12626TP

Brand Name

Clinpro™

Version/Model Number

12626TP

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

-

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

EBC

Product Code Name

SEALANT, PIT AND FISSURE, AND CONDITIONER

Device Record Status

Public Device Record Key

567e2d59-f0b4-4975-8297-1939ca11f016

Public Version Date

October 25, 2018

Public Version Number

1

DI Record Publish Date

September 24, 2018

Additional Identifiers

Package DI Number

50605861010738

Quantity per Package

10

Contains DI Package

30605861010734

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"3M COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 274
2 A medical device with a moderate to high risk that requires special controls. 444
U Unclassified 7