CRANEX 3D PAN ACCESSORIES

GUDID 06430035874439

PaloDEx Group Oy

Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block Seizure bite block

• Primary Device ID: 06430035874439
• NIH Device Record Key: d1394f9c-3fea-49b0-974f-dafb08dd78b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CRANEX 3D PAN ACCESSORIES
• Version Model Number: 900388
• Company DUNS: 459955188
• Company Name: PaloDEx Group Oy
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035874439 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133544

FDA Product Code

• EHA: Aligner, Beam, X-Ray

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-03
• Device Publish Date: 2021-05-26

Devices Manufactured by PaloDEx Group Oy

• 06430035875139 - ORTHOPANTOMOGRAPH™ OP 3D: 2024-03-22 OP 3D LX CEPH UPGRADE KIT
• 06430035875092 - ORTHOPANTOMOGRAPH™ OP 3D: 2023-10-10 ORTHOPANTOMOGRAPH™ OP 3D LX (PAN 3D)
• 06430035875108 - ORTHOPANTOMOGRAPH™ OP 3D: 2023-10-10 ORTHOPANTOMOGRAPH™ OP 3D LX (PAN, CEPH 3D)
• 06430035873630 - Orthopantomograph OP 3D: 2021-06-08
• 06430035874484 - OP 3D Carpus Holder: 2021-06-04 Carpus holder for Carpus imaging with Orthopantomograph OP 3D
• 06430035874354 - Bite blocks 10pcs OP 3D: 2021-06-03
• 06430035874422 - CRANEX 3D PAT POSIT ACCESSORIES: 2021-06-03
• 06430035874439 - CRANEX 3D PAN ACCESSORIES: 2021-06-03
• 06430035874439 - CRANEX 3D PAN ACCESSORIES: 2021-06-03