Guide Screw PC3548

GUDID 24053613285951

Guide Screw Ø 3,20mm

Gebr. Brasseler GmbH & Co. KG

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• Primary Device ID: 24053613285951
• NIH Device Record Key: c17321c7-a0c8-43a0-94c7-89d1b2b7e144
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guide Screw
• Version Model Number: PC3548
• Catalog Number: PC3548
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• 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: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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	14053613285954 [Primary]
GS1	24053613285951 [Package]; Contains: 14053613285954; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131264

FDA Product Code

• HWC: Screw, Fixation, Bone

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: 2023-08-01
• Device Publish Date: 2023-07-24

On-Brand Devices [Guide Screw]

• 24053613285951: Guide Screw Ø 3,20mm
• 24053613285920: Guide Screw Ø 3,20mm