AccessGUDID - DEVICE: SL-PLUS MIA (07611996079623)

GUDID

Device Identifier (DI) Information

Brand Name: SL-PLUS MIA
Version or Model: 75001950
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 75001950
Company Name: Smith & Nephew, Inc.

Primary DI Number: 07611996079623
Issuing Agency: GS1
Commercial Distribution End Date: March 02, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 109903521 *Terms of Use

Device Description: SL-PLUS MIA STEM 12 NON-CEM

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Press-fit femoral stem prosthesis	A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is contoured to enable fixation by pressing the distal end into the cortex of the remaining natural femur to achieve a mechanical interlock without the use of bone cement. The device is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel].

FDA Product Code

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Product Code	Product Code Name
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or 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

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a80439fe-3fd6-431c-9838-8c2f55d15aea
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: August 29, 2015