IntraBlock™ TwinStem™ - IntraBlock™ TwinStem™ non-cemented size 7.50 - Merete GmbH

Duns Number:313267265

Device Description: IntraBlock™ TwinStem™ non-cemented size 7.50 Standard 12/14 TiAl6V4 ELI TPS-Coating steri IntraBlock™ TwinStem™ non-cemented size 7.50 Standard 12/14 TiAl6V4 ELI TPS-Coating sterile

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More Product Details

Catalog Number

HR35007

Brand Name

IntraBlock™ TwinStem™

Version/Model Number

size 7.50 Standard

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 13, 2021

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

-

Product Code Details

Product Code

LZO

Product Code Name

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Device Record Status

Public Device Record Key

54162580-8258-4da6-bb43-df6427a3afa9

Public Version Date

December 14, 2021

Public Version Number

5

DI Record Publish Date

January 01, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MERETE GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 328
2 A medical device with a moderate to high risk that requires special controls. 1327
U Unclassified 13