SmarTemp® - SmarTemp® X1 Shade A1 (50ml 10:1 Cartridge) - PARKELL, INC.

Duns Number:009900424

Device Description: SmarTemp® X1 Shade A1 (50ml 10:1 Cartridge)

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More Product Details

Catalog Number

S346-A1

Brand Name

SmarTemp®

Version/Model Number

S346-A1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 15, 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

0407e94a-c2b8-4feb-bdac-3ae8597125e4

Public Version Date

October 29, 2021

Public Version Number

3

DI Record Publish Date

September 27, 2019

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