TSI PROSTHETIC KIT 4.0 TPK-OB

GUDID D78540TPKOB0

4.0MM TWO-STAGE O-BALL PROSTHETIC KIT

OCO BIOMEDICAL INC

Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog Dental implant analog

• Primary Device ID: D78540TPKOB0
• NIH Device Record Key: cbe250d9-084e-4207-9205-ee7c6cdd9c98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSI PROSTHETIC KIT
• Version Model Number: 4.0MM TWO-STAGE O-BALL PROSTHETIC KIT
• Catalog Number: 4.0 TPK-OB
• Company DUNS: 094146123
• Company Name: OCO BIOMEDICAL INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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	D78540TPKOB0 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-25
• Device Publish Date: 2024-04-17

On-Brand Devices [TSI PROSTHETIC KIT]

• D78550TPK0: 5.0MM TWO STAGE PROSTHETIC KIT
• D78540TPK0: 4.0MM TWO STAGE PROSTHETIC KIT
• D785325TPK0: 3.25MM TWO STAGE PROSTHETIC KIT
• D78540TPKOB0: 4.0MM TWO-STAGE O-BALL PROSTHETIC KIT