Synthacer - Synthacer® 1000 granules, "negative", HA, - medArtis Medizinprodukte und Forschung Aktiengesellschaft

Duns Number:313163545

Device Description: Synthacer® 1000 granules, "negative", HA, particle size 1.0 - 2.5 mm

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More Product Details

Catalog Number

6.N3G02

Brand Name

Synthacer

Version/Model Number

T6N3G02-1

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

Yes

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

K041177

Product Code Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

c4a1488d-ce15-4307-8ed3-52f06af20f9b

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

October 24, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDARTIS MEDIZINPRODUKTE UND FORSCHUNG AKTIENGESELLSCHAFT" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 753