SmartPractice - S/P IMPRESSION MATL VPS MED BODY 50ML*4 658-00474 - Smarthealth, Inc.

Duns Number:061081477

Device Description: S/P IMPRESSION MATL VPS MED BODY 50ML*4 658-00474

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More Product Details

Catalog Number

SP693128

Brand Name

SmartPractice

Version/Model Number

SP693128

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K801380,K801380,K801380

Product Code Details

Product Code

ELW

Product Code Name

MATERIAL, IMPRESSION

Device Record Status

Public Device Record Key

adab5f09-47fd-4a34-a941-278be956675b

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

D766SP6931282

Quantity per Package

10

Contains DI Package

D766SP6931281

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"SMARTHEALTH, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 8
U Unclassified 18