AccessGUDID - DEVICE: PATHWAY (10603295026860)

GUDID

Device Identifier (DI) Information

Brand Name: PATHWAY
Version or Model: 1299-01-030
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 129901030
Company Name: DEPUY INTERNATIONAL LTD

Primary DI Number: 10603295026860
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 896498813 *Terms of Use

Device Description: PATHWAY DISASSEMBLY DRIVER

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?
47866	Orthopaedic implant/instrument dismantling device	A device designed to dismantle (take apart) the component parts of an implant or a surgical instrument that have previously been assembled. It may be used as a stand-alone device or in combination with another device to control the dismantling process of, e.g., complex implants (e.g., a modular vertebral implant that has to be dismantled if the combination of the component parts do not fit the required size) or instruments so that these are correctly disassembled, without causing damage to any of the parts. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of shapes and lengths. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXX	SCREWDRIVER

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: 2bc5251e-135a-47fc-9ad8-683d29d2c4ce
Public Version Date: November 07, 2024
Public Version Number: 2
DI Record Publish Date: September 24, 2018