MALLET MALLET

GUDID D785MALLET0

Z-6309 MALLET

OCO BIOMEDICAL INC

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• Primary Device ID: D785MALLET0
• NIH Device Record Key: fefa58c0-72a5-426b-8292-c9f135fecb40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MALLET
• Version Model Number: Z-6309 MALLET
• Catalog Number: MALLET
• 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: false
• Device Combination Product: false
• Single Use: false
• 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	D785MALLET0 [Primary]

FDA Product Code

• DZN: Instruments, Dental Hand

Sterilization

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

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

[D785MALLET0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-20
• Device Publish Date: 2024-03-12

Devices Manufactured by OCO BIOMEDICAL INC

• D785AS3100TSI0 - TSI/ERI Abutment Screw: 2024-05-07 TSI/ERI Abutment Screw 3.25mm
• D785AS4100TSI0 - TSI/ERI Abutment Screw: 2024-05-07 TSI/ERI Abutment Screw 4.0/5.0mm
• D78529SDIOBPK0 - 2.9 SDI O-BALL PROSTHETIC KIT: 2024-04-29 2.9MM SDI O-BALL PROSTHETIC KIT
• D78540TPKOB0 - TSI PROSTHETIC KIT: 2024-04-25 4.0MM TWO-STAGE O-BALL PROSTHETIC KIT
• D785325ICBPK0 - ISI C&B PROSTHETIC KIT: 2024-04-17 3.25MM ISI CROWN & BRIDGE PROSTHETIC KIT
• D785002ORKIT0 - O-RING PACK: 2024-04-11 002 O-Ring Kit
• D785003ORKIT0 - O-RING PACK: 2024-04-11 003 O-Ring Kit
• D785002CAPWO0 - HOUSING CAP WITH O-RING: 2024-03-20 002 CAP WITH 002 BLK O-RING INSERTED