AccessGUDID - DEVICE: SMF, STIKTITE (03596010619648)

GUDID

Device Identifier (DI) Information

Brand Name: SMF, STIKTITE
Version or Model: 71352508
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 71352508
Company Name: Smith & Nephew, Inc.

Primary DI Number: 03596010619648
Issuing Agency: GS1
Commercial Distribution End Date: January 31, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 045483575 *Terms of Use

Device Description: SMF STEM WITH STIKTITE SZ 8

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?
38155	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].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K080625	000

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: 778ec345-8c4e-4e83-9e02-151114bce187
Public Version Date: September 07, 2023
Public Version Number: 4
DI Record Publish Date: August 30, 2015