Chromic Gut 5-0 18" C3 850-CG5018C3

GUDID D773850CG5018C31

Dental Health Products Inc

Catgut suture, chromic

• Primary Device ID: D773850CG5018C31
• NIH Device Record Key: bdf2154d-7b3a-466e-ba2f-5d3050bcdd48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Chromic Gut 5-0 18" C3
• Version Model Number: 850-CG5018C3
• Catalog Number: 850-CG5018C3
• Company DUNS: 623191194
• Company Name: Dental Health Products Inc
• Device Count: 1
• DM Exempt: true
• 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
HIBCC	D773850CG5018C31 [Primary]
HIBCC	D773850CG5018C32 [Package]; 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: 2017-01-24

Devices Manufactured by Dental Health Products Inc

• D7735901000721 - DHP/Health-Tec Sterilization Tape: 2023-04-03 DHP/Health-Tec Sterilization Tape 3/4" x 60 yard
• D7735901000821 - DHP/Health-Tec Sterilization Tape: 2023-04-03 DHP/Health-Tec Sterilization Tape 1" x 60 yard
• D7736001000320 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 DHP/Health-Tec Sterilization Pouches, 2.5" x 4" 200/box
• D7736001000420 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 Health-Tec Sterilization Pouches, 2.75" x 9" 200/box
• D7736001000520 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 Health-Tec Sterilization Pouches, 3.5" x 5.25"
• D7736001000620 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 Health-Tec Sterilization Pouches, 3.5" x 9" 200/box
• D7736001000720 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 Health-Tec Sterilization Pouches, 3.5" x 9", 500/box
• D7736001000820 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 Health-Tec Sterilization Pouches, 5.25" x 10" 200/box