AccessGUDID - DEVICE: CONFIDENCE SPINAL CEMENT SYSTEM (10705034462462)

GUDID

Device Identifier (DI) Information

Brand Name: CONFIDENCE SPINAL CEMENT SYSTEM
Version or Model: 283999001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 283999001
Company Name: DEPUY SPINE, LLC

Primary DI Number: 10705034462462
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 107105876 *Terms of Use

Device Description: CONFIDENCE SPINAL CEMENT SYSTEM CONFIDENCE NEEDLE ADAPTER

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?
56640	Orthopaedic implant-instrument extension adaptor, single-use	A sterile connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a single-use device.	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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 41 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit
Handling Environment Temperature: between 5 and 25 Degrees Celsius
Storage Environment Temperature: between 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ca14ea76-1f9b-4dee-a4b5-f2e382534a37
Public Version Date: May 03, 2023
Public Version Number: 3
DI Record Publish Date: December 31, 2016