CLASSIC BAG SIZE 0 200 PCS

GUDID 06430035873241

PaloDEx Group Oy

Medical equipment drape, single-use, non-sterile

• Primary Device ID: 06430035873241
• NIH Device Record Key: 9cca643f-86c7-45dd-8e4b-6b06d4333018
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CLASSIC BAG SIZE 0 200 PCS
• Version Model Number: 900670
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06430035873241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133231

FDA Product Code

• PEM: Dental Barriers And Sleeves

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: 2020-02-10
• Device Publish Date: 2020-02-01

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