GAMMA 3130-2170S

GUDID 04546540375148

Stryker Trauma GmbH

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• Primary Device ID: 04546540375148
• NIH Device Record Key: 122c0689-001c-4917-b99a-eea83460b32b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GAMMA
• Version Model Number: 3130-2170S
• Catalog Number: 3130-2170S
• Company DUNS: 330211587
• Company Name: Stryker Trauma GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• 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
GS1	04546540375148 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200869

FDA Product Code

• HSB: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-02
• Device Publish Date: 2021-11-24

On-Brand Devices [GAMMA]

• 07613327005530: Distal Targeting Device Gamma3 R1.5
• 07613252274513: Long Nail Kit R1.5, Ti, LEFT
• 07613252274506: Long Nail Kit R1.5, Ti, LEFT
• 07613252274490: Long Nail Kit R1.5, Ti, LEFT
• 07613252274483: Long Nail Kit R1.5, Ti, LEFT
• 07613252274476: Long Nail Kit R1.5, Ti, LEFT
• 07613252274469: Long Nail Kit R1.5, Ti, LEFT
• 07613252274452: Long Nail Kit R1.5, Ti, LEFT
• 07613252274445: Long Nail Kit R1.5, Ti, LEFT
• 07613252274438: Long Nail Kit R1.5, Ti, LEFT
• 07613252274421: Long Nail Kit R1.5, Ti, LEFT
• 07613252274414: Long Nail Kit R1.5, Ti, LEFT
• 07613252274407: Long Nail Kit R1.5, Ti, LEFT
• 07613252274391: Long Nail Kit R1.5, Ti, LEFT
• 07613252274384: Long Nail Kit R1.5, Ti, LEFT
• 07613252274377: Long Nail Kit R1.5, Ti, LEFT
• 07613252274360: Long Nail Kit R1.5, Ti, LEFT
• 07613252274353: Long Nail Kit R1.5, Ti, LEFT
• 07613252274346: Long Nail Kit R1.5, Ti, LEFT
• 07613252274339: Long Nail Kit R1.5, Ti, LEFT
• 07613252274322: Long Nail Kit R1.5, Ti, LEFT
• 07613252274315: Long Nail Kit R1.5, Ti, LEFT
• 07613252274308: Long Nail Kit R1.5, Ti, LEFT
• 07613252274292: Long Nail Kit R1.5, Ti, LEFT
• 07613252274285: Long Nail Kit R1.5, Ti, LEFT
• 07613252274278: Long Nail Kit R1.5, Ti, LEFT
• 07613252274261: Long Nail Kit R1.5, Ti, LEFT
• 07613252274254: Long Nail Kit R1.5, Ti, LEFT
• 07613252274247: Long Nail Kit R1.5, Ti, LEFT
• 07613252274230: Long Nail Kit R1.5, Ti, LEFT
• 07613252274223: Long Nail Kit R1.5, Ti, LEFT
• 07613252274216: Long Nail Kit R1.5, Ti, LEFT
• 07613252274209: Long Nail Kit R1.5, Ti, LEFT
• 07613252274193: Long Nail Kit R1.5, Ti, LEFT
• 07613252274186: Long Nail Kit R1.5, Ti, LEFT
• 07613252274179: Long Nail Kit R1.5, Ti, LEFT
• 07613252274162: Long Nail Kit R1.5, Ti, LEFT
• 07613252274155: Long Nail Kit R1.5, Ti, LEFT
• 07613252274148: Long Nail Kit R1.5, Ti, LEFT
• 07613252274131: Long Nail Kit R1.5, Ti, LEFT
• 07613252274124: Long Nail Kit R1.5, Ti, LEFT
• 07613252274117: Long Nail Kit R1.5, Ti, LEFT
• 07613252274100: Long Nail Kit R1.5, Ti, LEFT
• 07613252274094: Long Nail Kit R1.5, Ti, LEFT
• 07613252274087: Long Nail Kit R1.5, Ti, LEFT
• 07613252274070: Long Nail Kit R1.5, Ti, LEFT
• 07613252274063: Long Nail Kit R1.5, Ti, RIGHT
• 07613252274056: Long Nail Kit R1.5, Ti, RIGHT
• 07613252274049: Long Nail Kit R1.5, Ti, RIGHT
• 07613252274032: Long Nail Kit R1.5, Ti, RIGHT