Flow Dental 81500

GUDID 08717228441011

Confee Ears Disposable ear sleeves for CBCT exams

DuPhaMed B.V.

Medical equipment drape, single-use

• Primary Device ID: 08717228441011
• NIH Device Record Key: 6ca0df73-bdc8-4017-8a5b-2b0c0d656cd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flow Dental
• Version Model Number: Earflow34
• Catalog Number: 81500
• Company DUNS: 413491023
• Company Name: DuPhaMed B.V.
• Device Count: 150
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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	08717228440212 [Primary]
GS1	08717228441011 [Unit of Use]
GS1	08717228442537 [Primary]

FDA Product Code

• EGZ: Holder, Film, 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: 2023-12-01
• Device Publish Date: 2023-11-23

Devices Manufactured by DuPhaMed B.V.

• 08717228440038 - DenBite: 2023-12-04 X-Ray sensor holder Refill Pack Posterior Size 1, Content: 5x posterior Upper Left / Lower Right - UDI 08717228441554 5x poster
• 08717228440045 - DenBite: 2023-12-04 X-Ray sensor holder Refill Pack Posterior Size 2, Content: 5x posterior Upper Left / Lower Right - UDI 08717228441578 5x posteri
• 08717228440052 - DenBite: 2023-12-04 X-Ray sensor holder Refill Pack Periapical Size 1, Content: 5x periapical Upper Left / Lower Right - UDI 08717228441233 5x peri
• 08717228440069 - DenBite: 2023-12-04 X-Ray sensor holder Refill Pack Periapical Size 2, Content: 5x periapical Upper Left / Lower Right - UDI 08717228441387 5x peri
• 08717228440076 - DenBite: 2023-12-04 X-Ray sensor holder Refill Pack Endo Size 1, Content: 3x endo Upper Left / Lower Right - UDI 08717228441196 3x endo Upper Right
• 08717228440083 - DenBite: 2023-12-04 X-Ray sensor holder Refill Pack Endo Size 2, Content: 3x endo Upper Left / Lower Right - UDI 08717228441219 3x endo Upper Right
• 08717228440090 - DenBite: 2023-12-04 X-Ray sensor holder Introduction Pack Size 1, content: 1x bitewing - UDI 08717228441035 1x posterior Upper Left / Lower Right -
• 08717228440106 - DenBite: 2023-12-04 X-Ray sensor holder Introduction Pack Size 2, content: 1x bitewing - UDI 08717228441042 1x posterior Upper Left / Lower Right -