AccessGUDID - DEVICE: INSTRUMENT (07613327227987)

GUDID

Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 6488-5-075
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6488-5-075
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327227987
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: MRS TRIAL HUMERAL STEM WITHOUT BODY

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:	No
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?
60936	Humeral stem prosthesis trial, reusable	A copy of a final humeral stem prosthesis designed to be used before primary or revision implant surgery to validate the proper size of the permanent prosthesis required by the patient and to ensure its proper orientation and positioning. It is typically made of metal and/or synthetic polymer. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Device Size Text, specify: Diameter: 7.0 Millimeter
Length: 75.0 Millimeter

Device Record Status

Public Device Record Key: 0820a930-32b7-4782-9fcc-ab6b213ffa54
Public Version Date: September 25, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2016