Orthopedic Manual Surgical Instrument

GUDID 04719875721243

Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic procedures to assist implantation of Wiltrom implants. The Wiltrom Orthopedic Surgical Instruments are provided non-sterile and must be sterilized prior to use.

WILTROM CO., LTD.

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• Primary Device ID: 04719875721243
• NIH Device Record Key: c732cd0f-9c24-46a9-b9d3-b60411ef1bbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orthopedic Manual Surgical Instrument
• Version Model Number: 75046 Pin M1.2*L121mm
• Company DUNS: 656680902
• Company Name: WILTROM CO., LTD.
• Device Count: 10
• 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

Customer Support Contacts

• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw
• Phone: +88636107168
• Email: service@wiltrom.com.tw

Operating and Storage Conditions

• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius
• Storage Environment Temperature: Between 23 Degrees Celsius and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719875721243 [Primary]
GS1	04719875729751 [Unit of Use]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

[04719875721243]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-08
• Device Publish Date: 2022-11-30

On-Brand Devices [Orthopedic Manual Surgical Instrument]

• 04719875729782: Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic
• 04719875729775: Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic
• 04719875729768: Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic
• 04719875729751: Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic
• 04719875729744: Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic
• 04719875721243: Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic
• 04719875721236: Wiltrom Orthopedic Surgical Instruments are manual instruments designed to be used in orthopedic