Burkhart 3-0 Plain Gut Suture 27", C-6 Needle

GUDID 10854212006049

BURKHART DENTAL SUPPLY CO., THE

Catgut suture, plain

• Primary Device ID: 10854212006049
• NIH Device Record Key: f2f5eb41-2e03-4a07-a4d1-be9df55622a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Burkhart 3-0 Plain Gut Suture 27", C-6 Needle
• Version Model Number: 72720763
• 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	00854212006042 [Primary]
GS1	10854212006049 [Package]; Contains: 00854212006042; 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

Devices Manufactured by BURKHART DENTAL SUPPLY CO., THE

• 00815878027628 - Burkhart Dental Supply: 2024-05-15 Burkhart Etch 40% Phosphoric Acid Kit 1.2mL (4)
• 00815878027642 - Burkhart Dental Supply: 2024-05-15 Burkhart Etch Syringe Bulk Refill 40% Syr 30mL
• 00810052614458 - Burkhart Dental Supply: 2024-02-05 Premium Flowable Composite A3/A3.5/B3 Value Pack 3-1g Syr, 25-20G Tips
• 00810052614557 - Burkhart Dental Supply: 2024-02-05 Premium Flowable Composite A2/B2 Value Pack 3-1g Syr, 25-20G Tips
• 00810052614564 - Burkhart Dental Supply: 2024-02-05 Premium Flowable Composite A1/B1 Value Pack 3-1g Syr, 25-20G Tips
• 00810052615042 - Burkhart Dental Supply: 2024-02-05 HP Mixing Tip - Green 6.5mm (50 pack)
• 00810052615899 - Burkhart Dental Supply: 2024-02-05 HP Mixing Tip - Yellow 4.2mm (50 pack)
• 00810052616780 - Burkhart Dental Supply: 2024-02-05 HP Mixing Tip - Purple 7.5mm (50 pack)