Health-Tec Sterilization Pouches 600-10007

GUDID D773600100071

Health-Tec Sterilization Pouches, 3.5" x 10", Bulk Pack

Dental Health Products Inc

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• Primary Device ID: D773600100071
• NIH Device Record Key: b15b9ce6-5771-4419-b2ee-5bc41e40d9fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health-Tec Sterilization Pouches
• Version Model Number: 600-10007
• Catalog Number: 600-10007
• Company DUNS: 623191194
• Company Name: Dental Health Products 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D773600100070 [Unit of Use]
HIBCC	D773600100071 [Primary]
HIBCC	D773600100072 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143637

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

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: 2019-11-08
• Device Publish Date: 2017-01-17

On-Brand Devices [Health-Tec Sterilization Pouches]

• D773600100091: Health-Tec Sterilization Pouches, 7.5" x 13"
• D773600100081: Health-Tec Sterilization Pouches, 5.25" x 10"
• D773600100071: Health-Tec Sterilization Pouches, 3.5" x 10", Bulk Pack
• D773600100062: Health-Tec Sterilization Pouches, 3.5" x 10"
• D773600100052: Health-Tec Sterilization Pouches, 3.5" x 5.25"
• D773600100042: Health-Tec Sterilization Pouches, 2.75" x 10"
• D773600100032: Health-Tec Sterilization Pouches, 2.5" x 4"