gSource gS 78.5720

GUDID M7557857200

Stein. Pin D. Trocar 12" 2.0mm [.079"] pkg/6

GSOURCE LLC

Orthopaedic bone wire

• Primary Device ID: M7557857200
• NIH Device Record Key: 76b51a6d-07bc-4e83-86de-18fe87355344
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gSource
• Version Model Number: gS 78.5720
• Catalog Number: gS 78.5720
• Company DUNS: 008162518
• Company Name: GSOURCE LLC
• Device Count: 1
• 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	M7557857200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100736

FDA Product Code

• HTY: Pin, Fixation, Smooth

Sterilization

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

[M7557857200]

Moist Heat or Steam Sterilization

[M7557857200]

Moist Heat or Steam Sterilization

[M7557857200]

Moist Heat or Steam Sterilization

[M7557857200]

Moist Heat or Steam Sterilization

[M7557857200]

Moist Heat or Steam Sterilization

[M7557857200]

Moist Heat or Steam Sterilization

[M7557857200]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-27
• Device Publish Date: 2021-07-19

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