XIOS XG

GUDID D76464099521

XIOS XG SELECT SIZE 2 SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG)

SIRONA DENTAL, INC.

Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile

• Primary Device ID: D76464099521
• NIH Device Record Key: 2d3defe2-0b75-4726-b4e0-ee7d1c531e38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XIOS XG
• Version Model Number: 6409952
• Company DUNS: 078613913
• Company Name: SIRONA DENTAL, INC.
• Device Count: 300
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com
• Phone: (877) 724-4254
• Email: customerserviceny@sirona.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D76464099520 [Unit of Use]
HIBCC	D76464099521 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132953

FDA Product Code

• PEM: Dental Barriers And Sleeves

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-12-09
• Device Publish Date: 2016-09-09

On-Brand Devices [XIOS XG]

• D76465455991: AimRight Aiming Ring, Red 1pc
• D76465456151: XIOS XG AimRight Grip Sensor Holder Kit S2
• D76465456071: XIOS XG AimRight Grip Sensor Holder Kit S1
• D76465455811: AimRight Sensor Holder, Ant/Blue S2 2pc
• D76465455731: AimRight Sensor Holder, Ant/Blue S1 2pc
• D76465455651: AimRight Sensor Holder, BW/Red S2 2pc
• D76465455571: AimRight Sensor Holder, BW/Red S1 2pc
• D76465455401: AimRight Sensor Holder, PA/Yel. S2 4pc
• D76465455321: AimRight Sensor Holder, Posterior/Yellow. S1 4pc
• D76464112971: XIOS XG S2 STARTER KIT
• D76464112891: XIOS XG S1 STARTER KIT
• D76461774011: USB A/B 3M BLACK CABLE REPLACEMENT W/FERRITE
• D76464099601: XIOS XG SELECT SIZE 1 SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG)
• D76464099521: XIOS XG SELECT SIZE 2 SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG)