AccessGUDID - DEVICE: Paragon (09340499024783)

GUDID

Device Identifier (DI) Information

Brand Name: Paragon
Version or Model: GM08001-349-07
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GM08001-349-07
Company Name: GLOBAL MANUFACTURING TECHNOLOGY PTY LIMITED

Primary DI Number: 09340499024783
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 752039982 *Terms of Use

Device Description: Paragon Distal Broach Size 7 - Male (Omni)

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?
36167	Orthopaedic broach	A surgical instrument that is designed as an elongated, tapered and serrated cutting tool intended for shaping and enlarging holes in bone tissue. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MEH	Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123782	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
Device Size Text, specify: Size 7

Device Record Status

Public Device Record Key: f2f164eb-e8ca-4893-9858-dea4c36fbef3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016