gSource gS 78.2050

GUDID M7557820501

K-Wire D. Trocar 5" 0.7mm [.028"] pkg/6

GSOURCE LLC

Orthopaedic bone wire

• Primary Device ID: M7557820501
• NIH Device Record Key: 722c058b-56f6-4019-8aca-7e29ceefef2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gSource
• Version Model Number: 78.2050
• Catalog Number: gS 78.2050
• Company DUNS: 008162518
• Company Name: GSOURCE LLC
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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	M7557820500 [Unit of Use]
HIBCC	M7557820501 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100736

FDA Product Code

• KDW: Container, Specimen Mailer And Storage, Temperature Controlled, Sterile

Sterilization

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

[M7557820501]

Moist Heat or Steam Sterilization

[M7557820501]

Moist Heat or Steam Sterilization

[M7557820501]

Moist Heat or Steam Sterilization

[M7557820501]

Moist Heat or Steam Sterilization

[M7557820501]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-07-26
• Device Publish Date: 2017-03-31

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