TSI PROSTHETIC KIT 4.0 TPK-OB

GUDID D78540TPKOB0

4.0MM TWO-STAGE O-BALL PROSTHETIC KIT

OCO BIOMEDICAL INC

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