Needle Guide Bracket Kit

GUDID 06944413811706

Edan Instruments, Inc.

Ultrasound imaging system tracking holder, reusable

• Primary Device ID: 06944413811706
• NIH Device Record Key: c81a61b1-1d1b-49ec-b015-f0ff201b275d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Needle Guide Bracket Kit
• Version Model Number: BGK-C5-2
• Company DUNS: 529173163
• Company Name: Edan Instruments, Inc.
• 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: false
• Lot Batch: false
• Serial Number: true
• 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	06944413811706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180862

FDA Product Code

• ITX: Transducer, Ultrasonic, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-23
• Device Publish Date: 2018-09-30

On-Brand Devices [Needle Guide Bracket Kit]

• 06944413811867: BGK-P5-1X
• 06944413811850: BGK-L50UB
• 06944413811843: BGK-R20UB
• 06944413811836: BGK-R15UB
• 06944413811829: BGK-R10UB
• 06944413811812: BGK-CR10UA
• 06944413811805: BGK-L40UB
• 06944413811799: BGK-R50UB
• 06944413811737: BGK-001
• 06944413811720: BGK-L40UB
• 06944413811713: BGK-R15UB
• 06944413811706: BGK-C5-2
• 06944413812703: BGK-008
• 06944413811751: BGK-003
• 06944413811744: BGK-002
• 06944413811959: BGK-007
• 06944413811782: BGK-006
• 06944413811775: BGK-005
• 06944413811768: BGK-004
• 06944413813939: BGK-009