Burkhart Sterile Pouches 7-1/2" x 13" (200)

GUDID 00815878021053

BURKHART DENTAL SUPPLY CO., THE

Sterilization packaging, single-use

• Primary Device ID: 00815878021053
• NIH Device Record Key: 7104cc84-52b4-4b42-967e-eaed8aff5628
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burkhart Sterile Pouches 7-1/2" x 13" (200)
• Version Model Number: 72720843
• Company DUNS: 027532357
• Company Name: BURKHART DENTAL SUPPLY CO., THE
• Device Count: 200
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com
• Phone: 800-562-8176
• Email: customerservice@burkhartdental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815878021053 [Primary]
GS1	00815878021060 [Unit of Use]
GS1	10815878021050 [Package]; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941327

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-04-13

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