SCHICK

GUDID D764B63101201

USBCAM DISPOSABLE SHEATHS (500/PK) 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: D764B63101201
• NIH Device Record Key: afc4e345-ff07-4925-b3a1-dfc3b916e513
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCHICK
• Version Model Number: B6310120
• Company DUNS: 078613913
• Company Name: SIRONA DENTAL, INC.
• Device Count: 500
• 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	D764B63101200 [Unit of Use]
HIBCC	D764B63101201 [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 [SCHICK]

• D764B10700251: UNIVERSAL SENSOR HOLSTER
• D764B63101201: USBCAM DISPOSABLE SHEATHS (500/PK) UNIVERSAL SHEATHS SIZE 1 (300/PKG)
• D764B63101001: CDRCAM2 DISPOSABLE SHEATHS 500/PK - BLACK CAMERA UNIVERSAL SHEATHS SIZE 1 (300/PKG)
• D764B63061000: USB CAM4
• D764B63060111: USB CAM4 Upgrade Kit
• D764B6306010R1: USBCam4 Replacement
• D764B63060001: USBCAM4 KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
• D764B63031000: USB CAM
• D764B6303010R1: USBCam Replacement
• D764B63030001: USBCAM KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)
• D764B12100300: CDRW S2 300 SENSOR SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG)
• D764B10700090: UNIVERSAL SHEATHS SIZE 2 (300/PKG) UNIVERSAL SHEATHS SIZE 1 (300/PKG)
• D764B10700080: UNIVERSAL SHEATHS SIZE 1 (300/PKG) UNIVERSAL SHEATHS SIZE 1 (300/PKG)