HyFlex CM

GUDID D661SBH831LRG0

HYFLEX CM FILE ASST LRG 31MM

COLTENE/WHALEDENT INC

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• Primary Device ID: D661SBH831LRG0
• NIH Device Record Key: 7f405944-8306-4442-8a43-eb3dc3fb57b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HyFlex CM
• Version Model Number: SBH831LRG
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com
• Phone: 3309168800
• Email: info@coltene.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D661SBH831LRG0 [Unit of Use]
HIBCC	D661SBH831LRG1 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-30
• Device Publish Date: 2023-06-22

On-Brand Devices [HyFlex CM]

• D661SBHNT825SML0: HYFLEX NT FILE ASST SMALL 25MM
• D661SBHNT825MED0: HYFLEX NT FILE ASST MED 25MM
• D661SBHNT825LRG0: HYFLEX NT FILE ASST LRG 25MM
• D661SBHNT82506400: HYFLEX NT FILE 25MM 06/40 6PK
• D661SBHNT82506350: HYFLEX NT FILE 25MM 06/35 6PK
• D661SBHNT82506300: HYFLEX NT FILE 25MM 06/30 6PK
• D661SBHNT82506250: HYFLEX NT FILE 25MM 06/25 6PK
• D661SBHNT82506200: HYFLEX NT FILE 25MM 06/20 6PK
• D661SBHNT82504600: HYFLEX NT FILE 25MM 04/60 6PK
• D661SBHNT82504500: HYFLEX NT FILE 25MM 04/50 6PK
• D661SBHNT82504450: HYFLEX NT FILE 25MM 04/45 6PK
• D661SBHNT82504400: HYFLEX NT FILE 25MM 04/40 6PK
• D661SBHNT82504350: HYFLEX NT FILE 25MM 04/35 6PK
• D661SBHNT82504300: HYFLEX NT FILE 25MM 04/30 6PK
• D661SBHNT82504250: HYFLEX NT FILE 25MM 04/25 6PK
• D661SBHNT82504200: HYFLEX NT FILE 25MM 04/20 6PK
• D661SBHNT82504150: HYFLEX NT FILE 25MM 04/15 6PK
• D661SBHNT821SML0: HYFLEX NT FILE ASST SMALL 21MM
• D661SBHNT821MED0: HYFLEX NT FILE ASST MED 21MM
• D661SBHNT821LRG0: HYFLEX NT FILE ASST LRG 21MM
• D661SBHNT82106400: HYFLEX NT FILE 21MM 06/40 6PK
• D661SBHNT82106350: HYFLEX NT FILE 21MM 06/35 6PK
• D661SBHNT82106300: HYFLEX NT FILE 21MM 06/30 6PK
• D661SBHNT82106250: HYFLEX NT FILE 21MM 06/25 6PK
• D661SBHNT82106200: HYFLEX NT FILE 21MM 06/20 6PK
• D661SBHNT82104600: HYFLEX NT FILE 21MM 04/60 6PK
• D661SBHNT82104500: HYFLEX NT FILE 21MM 04/50 6PK
• D661SBHNT82104450: HYFLEX NT FILE 21MM 04/45 6PK
• D661SBHNT82104400: HYFLEX NT FILE 21MM 04/40 6PK
• D661SBHNT82104350: HYFLEX NT FILE 21MM 04/35 6PK
• D661SBHNT82104300: HYFLEX NT FILE 21MM 04/30 6PK
• D661SBHNT82104250: HYFLEX NT FILE 21MM 04/25 6PK
• D661SBHNT82104200: HYFLEX NT FILE 21MM 04/20 6PK
• D661SBHNT82104150: HYFLEX NT FILE 21MM 04/15 6PK
• D661SBHGPF831ASST0: GLIDEPATH FILE ASST 31 MM
• D661SBHGPF83120020: GPF CMK 20/02 X 31MM FILE 6PK
• D661SBHGPF83115020: GPF CMK 15/02 X 31MM FILE 6PK
• D661SBHGPF83115010: GPF NAV 15/01 X 31MM FILE 6PK
• D661SBHGPF825ASST0: GLIDEPATH FILE ASST 25 MM
• D661SBHGPF82520020: GPF CMK 20/02 X 25MM FILE 6PK
• D661SBHGPF82515020: GPF CMK 15/02 X 25MM FILE 6PK
• D661SBHGPF82515010: GPF NAV 15/01 X 25MM FILE 6PK
• D661SBHGPF821ASST0: GLIDEPATH FILE ASST 21 MM
• D661SBHGPF82120020: GPF CMK 20/02 X 21MM FILE 6PK
• D661SBHGPF82115020: GPF CMK 15/02 X 21MM FILE 6PK
• D661SBHGPF82115010: GPF NAV 15/01 X 21MM FILE 6PK
• D661SBH831SML0: HYFLEX CM FILE ASST SML 31MM
• D661SBH831MED0: HYFLEX CM FILE ASST MED 31MM
• D661SBH831LRG0: HYFLEX CM FILE ASST LRG 31MM
• D661SBH83106400: HYFLEX CM FILE 06/40 31MM 6PK