SNAP™ - 170gm SNAP™ Resin Shade 69 - PARKELL, INC.

Duns Number:009900424

Device Description: 170gm SNAP™ Resin Shade 69

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More Product Details

Catalog Number

S450

Brand Name

SNAP™

Version/Model Number

S450

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 10, 2021

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

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

2d559f86-e25f-4186-817c-50ad24474228

Public Version Date

September 22, 2022

Public Version Number

3

DI Record Publish Date

November 02, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARKELL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 476
U Unclassified 19