Burkhart 3-0 Plain Gut Suture 18", C-31 Needle

GUDID 10854212006032

BURKHART DENTAL SUPPLY CO., THE

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• Primary Device ID: 10854212006032
• NIH Device Record Key: 7516c243-12a2-46c8-a1c7-f6f3146f6cd1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burkhart 3-0 Plain Gut Suture 18", C-31 Needle
• Version Model Number: 72720755
• Company DUNS: 027532357
• Company Name: BURKHART DENTAL SUPPLY CO., THE
• Device Count: 1
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854212006035 [Primary]
GS1	10854212006032 [Package]; Contains: 00854212006035; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896554

FDA Product Code

• GAL: Suture, Absorbable, Natural

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-03-03

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