AccessGUDID - DEVICE: Seitz Solution Unlar Head (B033KCUH1617)

GUDID

Device Identifier (DI) Information

Brand Name: Seitz Solution Unlar Head
Version or Model: KCUH-1617
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KCUH-1617
Company Name: Kapp Surgical Instrument Co.

Primary DI Number: B033KCUH1617
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004171112 *Terms of Use

Device Description: 16.5x17mm Ulnar 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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33720	Wrist ulna-head prosthesis	A sterile implantable device designed to replace the distal ulnar head of the radio-ulnar joint following ulnar head resection typically due to arthritis, post-traumatic disabilities (pain, weakness, instability), or failed alternative treatment. It may be a one-piece or modular device made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel] and/or polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KXE	Prosthesis, Wrist, Hemi-, Ulnar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033930	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

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4c6a70dc-78bc-4636-b740-a18179197a7b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 24, 2015