OP 3D Carpus Holder

GUDID 06430035874484

Carpus holder for Carpus imaging with Orthopantomograph OP 3D

PaloDEx Group Oy

Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system Limited-view-field CT system

• Primary Device ID: 06430035874484
• NIH Device Record Key: 3c393923-d76d-4650-92d7-a1f3b026c7be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OP 3D Carpus Holder
• Version Model Number: 901074
• 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	06430035874484 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180947

FDA Product Code

• IWY: Holder, Head, Radiographic

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: 2021-06-04
• Device Publish Date: 2021-05-27

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: 2021-06-04Carpus holder for Carpus imaging with Orthopantomograph OP 3D
• 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