Disposable Pre-calibrated Suction Charr. 8 52184-01

GUDID 04056481141165

Disposable suction 2.7 mm

Brainlab AG

Optical surgical navigation device tracking system suction cannula

• Primary Device ID: 04056481141165
• NIH Device Record Key: c162ef86-3d34-4087-8d62-506f3a897093
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Pre-calibrated Suction Charr. 8
• Version Model Number: 52184-01
• Catalog Number: 52184-01
• Company DUNS: 314482980
• Company Name: Brainlab AG
• 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: true
• Serial Number: true
• 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	04056481141158 [Package]; Package: [10 Units]; In Commercial Distribution
GS1	04056481141165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201752

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

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: 2021-03-16
• Device Publish Date: 2021-03-08

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• 04056481125967 - Patient Mask Set: 2025-03-18
• 04056481142698 - Frameless SRS MASK SET CRANIAL: 2025-03-18
• 04056481142704 - Frameless SRS MASK SET EXTENDED: 2025-03-18
• 04056481145620 - Alignment Reduction Tube Cranial 8.0 mm / 10.0 mm: 2025-03-04
• 04056481145637 - Alignment Guide Tube Cranial 4.9 mm / 8.0 mm: 2025-03-04
• 04056481145903 - Alignment Bone Anchor Cranial 2.1 mm / 4.9 mm: 2025-03-04