Medro Mallet With Plastic Caps 12-251-25

GUDID G25012251250

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.

N S SURGICAL COMPANY

Surgical mallet

• Primary Device ID: G25012251250
• NIH Device Record Key: e05850fb-e412-42ad-9d4d-6ea753c7ac7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medro Mallet With Plastic Caps
• Version Model Number: 12-251-25
• Catalog Number: 12-251-25
• Company DUNS: 645681649
• Company Name: N S SURGICAL COMPANY
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	G25012251250 [Primary]

FDA Product Code

• FZY: Hammer, Surgical

Sterilization

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

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

[G25012251250]

Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-08
• Device Publish Date: 2023-04-29

Devices Manufactured by N S SURGICAL COMPANY

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• G25012083230 - Bone Hooks 23cm: 2023-09-11 A hand-held, surgical instrument used for hooking around or into bone, typically to grasp, hold, and apply traction to the bone
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• G25012191240 - Lambotte Osteotomes Straight 38mm: 2023-09-11 A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic proced
• G25012195240 - Lambotte Osteotomes Curved 13mm: 2023-09-11 A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic proced