AeroDR Stitching Barrier Unit

GUDID 04560141936768

KONICA MINOLTA, INC.

Radiation shielding panel, portable/mobile

• Primary Device ID: 04560141936768
• NIH Device Record Key: 718cac70-e5bc-41a1-8af6-a9314f02e44f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AeroDR Stitching Barrier Unit
• Version Model Number: A5EX
• Company DUNS: 692076161
• Company Name: KONICA MINOLTA, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	04560141936768 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120752

FDA Product Code

• KPR: System, X-Ray, Stationary

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-21
• Device Publish Date: 2016-09-19

Devices Manufactured by KONICA MINOLTA, INC.

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• 04560141949287 - P-65: 2022-11-25
• 04560141949294 - P-75: 2022-11-25
• 04560141950276 - P-95: 2022-11-21