SmartPractice - S/P IMPRESSION MATL VPS LT BODY R/S 50ML CART*4 - Smarthealth, Inc.

Duns Number:061081477

Device Description: S/P IMPRESSION MATL VPS LT BODY R/S 50ML CART*4 658-00472

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More Product Details

Catalog Number

SP693127

Brand Name

SmartPractice

Version/Model Number

SP693127

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

21b2c5d2-2f97-4731-a48c-09b3d68eddb7

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 15, 2016

Additional Identifiers

Package DI Number

D766SP6931272

Quantity per Package

10

Contains DI Package

D766SP6931271

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