X-Gut™ Chromic Gut Suture

GUDID D765GC5016P451

Chromic Gut, USP 5-0, 16 mm 3/8 Circle Precision Point Reverse Cutting Needle

Osteogenics Biomedical Inc

Catgut suture, chromic

• Primary Device ID: D765GC5016P451
• NIH Device Record Key: 719fffca-dc51-4d6c-bc5e-5985d2b44e20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-Gut™ Chromic Gut Suture
• Version Model Number: GC5016P45
• Company DUNS: 123853058
• Company Name: Osteogenics Biomedical Inc
• 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: true
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 18 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D765GC5016P450 [Primary]
HIBCC	D765GC5016P451 [Package]; Contains: D765GC5016P450; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072930

FDA Product Code

• GAL: Suture, Absorbable, Natural

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-09
• Device Publish Date: 2025-09-01

On-Brand Devices [X-Gut™ Chromic Gut Suture]

• D765GC5019451: Chromic Gut, USP 5-0, 19 mm 3/8 Circle Reverse Cutting Needle
• D765GC5016P451: Chromic Gut, USP 5-0, 16 mm 3/8 Circle Precision Point Reverse Cutting Needle
• D765GC5013P451: Chromic Gut, USP 5-0, 13 mm 3/8 Circle Precision Point Reverse Cutting Needle
• D765GC4019P451: Chromic Gut, USP 4/0, 19 mm 3/8 Circle Precision Point Reverse Cutting Needle
• D765GC4019751: Chromic Gut, USP 4-0, 19 mm 3/8 Circle Reverse Cutting Needle
• D765GC4019451: Chromic Gut, USP 4-0, 19 mm 3/8 Circle Reverse Cutting Needle
• D765GC4013P451: Chromic Gut, USP 4/0, 13 mm 3/8 Circle Precision Point Reverse Cutting Needle
• D765GC3019P751: Chromic Gut, USP 3/0, 19 mm 3/8 Circle Precision Point Reverse Cutting Needle
• D765GC3019P451: Chromic Gut, USP 3/0, 19 mm 3/8 Circle Precision Point Reverse Cutting Needle
• D765GC3019751: Chromic Gut, USP 3-0, 19 mm 3/8 Circle Reverse Cutting Needle
• D765GC3019451: Chromic Gut, USP 3-0, 19 mm 3/8 Circle Reverse Cutting Needle