AccessGUDID - DEVICE: IntraBlock™ TwinStem™ (04048266003959)

GUDID

Device Identifier (DI) Information

Brand Name: IntraBlock™ TwinStem™
Version or Model: size 12.50 Lateral
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HR31012
Company Name: Merete GmbH

Primary DI Number: 04048266003959
Issuing Agency: GS1
Commercial Distribution End Date: December 13, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 313267265 *Terms of Use

Device Description: IntraBlock™ TwinStem™ non-cemented size 12.50 Lateral 12/14 TiAl6V4 ELI TPS-Coating sterile

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33581	Coated hip femur prosthesis, modular	A sterile implantable principal component of a total hip prosthesis (femoral component) designed to replace the femoral head and neck; the device is composed of two or more separate pieces (e.g., head, neck, and stem) designed to be joined and is coated with a material (e.g., porous materials, hydroxyapatite) intended to improve fixation and stability by promoting bone ingrowth. The device may be made of metal and/or ceramic materials. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 75684482-b0f1-48e8-9a4a-7e1c9169c9ea
Public Version Date: May 12, 2023
Public Version Number: 8
DI Record Publish Date: January 01, 2017