ALGINELLE - Orange alginate type 1 - free sample (18 g) - LASCOD SPA

Duns Number:436269609

Device Description: Orange alginate type 1 - free sample (18 g)

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More Product Details

Catalog Number

KAL902

Brand Name

ALGINELLE

Version/Model Number

KAL902

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)

-

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

ELW

Product Code Name

Material, Impression

Device Record Status

Public Device Record Key

b36a2390-abea-4dd8-af31-05090546475c

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"LASCOD SPA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10