AccessGUDID - DEVICE: Diamond Orthopedic, LLC (B551DMD319292)

GUDID

Device Identifier (DI) Information

Brand Name: Diamond Orthopedic, LLC
Version or Model: DMD-319-292
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DMD-319-292
Company Name: DIAMOND ORTHOPEDIC, LLC

Primary DI Number: B551DMD319292
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080596041 *Terms of Use

Device Description: Cleaning Stylet - 1.1mm, Length 150mm

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):	No
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?
44802	Orthopaedic instrument cleaning tool	A hand-held manual device designed to clean the residual tissue or debris that remains embedded on or in an orthopaedic surgical instrument (e.g., reamers, bone taps) following use. The device can be in the form of wire or a strip of metal. This is a reusable device.	Obsolete	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
No Device Sizes

Device Record Status

Public Device Record Key: d3a6e6da-a344-46a7-9685-3d8492cd0b1e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 29, 2017