NexxZr™ S / Z-95-20-NS-B100-SD - https://gudid.fda.gov/gudid/app/admin/udi/recordDe - SAGEMAX BIOCERAMICS, INC

Duns Number:002265727

Device Description: https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLo https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#

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More Product Details

Catalog Number

-

Brand Name

NexxZr™ S / Z-95-20-NS-B100-SD

Version/Model Number

Z-42061

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 18, 2018

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)

-

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

EIH

Product Code Name

Powder, Porcelain

Device Record Status

Public Device Record Key

5b34d6f1-b01d-4875-bb68-195476729295

Public Version Date

July 24, 2018

Public Version Number

2

DI Record Publish Date

March 26, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SAGEMAX BIOCERAMICS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 20
2 A medical device with a moderate to high risk that requires special controls. 3547