AccessGUDID - DEVICE: Seitz Solution Radial Head (B033KCHI2313)

GUDID

Device Identifier (DI) Information

Brand Name: Seitz Solution Radial Head
Version or Model: KCHI-2313
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KCHI-2313
Company Name: Kapp Surgical Instrument Co.

Primary DI Number: B033KCHI2313
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004171112 *Terms of Use

Device Description: 23x13mm Radial Head

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
Elbow radius prosthesis	A sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

GMDN Preferred Term Name

GMDN Definition

Elbow radius prosthesis

A sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

FDA Product Code

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Product Code	Product Code Name
KWI	Prosthesis, Elbow, Hemi-, Radial, Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K030237	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

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: fd8c5711-85ef-4405-bad3-cffe45d5ea6a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015