Home GUDID D785MALLET0 MALLET
Primary DI D785MALLET0
Brand MALLET
Company OCO BIOMEDICAL INC
Model Z-6309 MALLET
Catalog number MALLET
Device description Z-6309 MALLET
Published 2024-03-12
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name DZN Instruments, Dental Hand
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DZN Instruments, Dental Hand Dental 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D785MALLET0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Surgical mallet A hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 094146123 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D785OTCAP100 10 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT OT CAP 10 OT CAP 10 2026-02-04 D785OTCAP40 4 PACK OT EQUATOR HOUSING CAP WITH BLACK INSERT OT CAP 4 OT CAP 4 2026-02-04 D785OTPINK40 4 PACK OT EQUATOR PINK INSERTS OT PINK 4 OT PINK 4 2026-02-04 D785OTPU20 2 PACK OT EQUATOR IMPRESSION COPING OT PU 2 OT PU 2 2026-02-04 D785OTYELLOW40 4 PACK OT EQUATOR YELLOW INSERT OT YELLOW 4 OT YELLOW 4 2026-02-04 D78589490 TSI/ERI Locator Abutment Locator Abutment 0mm 8949 2025-09-03 D785325SB0 SCAN BODY TSI/ERI 3.25MM SCAN BODY 3.25 SB 2024-06-26 D78540SB0 SCAN BODY TSI/ERI 4.0MM SCAN BODY 4.0 SB 2024-06-26 D78550SB0 SCAN BODY TSI/ERI 5.0MM SCAN BODY 5.0 SB 2024-06-26 D78532530SA0 SCAN ADAPTER 3.25MM ENGAGE PEEK SCAN ADAPTER 32530 SA 2024-03-12 D78532530SB0 SCAN BODY 3.25MM ENGAGE SCAN BODY 32530 SB 2024-03-12 D7854035SA0 SCAN ADAPTER 4.0MM ENGAGE PEEK SCAN ADAPTER 4035 SA 2024-03-12 D7854035SB0 SCAN BODY 4.0MM ENGAGE SCAN BODY 4035 SB 2024-03-12 D7855045SA0 SCAN ADAPTER 5.0MM ENGAGE PEEK SCAN ADAPTER 5045 SA 2024-03-12 D7855045SB0 SCAN BODY 5.0MM ENGAGE SCAN BODY 5045 SB 2024-03-12 D7856057SA0 SCAN ADAPTER 6.0MM ENGAGE PEEK SCAN ADAPTER 6057 SA 2024-03-12 D7856057SB0 SCAN BODY 6.0MM ENGAGE SCAN BODY 6057 SB 2024-03-12 D7850330T0 Osteotomy Former 3.3mm Osteotomy Former 0330TN 2024-12-03 D7853610ENGAGE0 Two Stage Bone Level Dental Implant Engage 3610 ENGAGE 2024-12-03 D7853610ENGPLS0 Two Stage Bone Level Implant Engage Plus 3610 Engage Plus 2024-12-03
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