OdneClean A-0006

GUDID 07649988629310

OdneClean barrier sleeves, 100pcs per box.

Minitube AB

Medical equipment drape, single-use

• Primary Device ID: 07649988629310
• NIH Device Record Key: cfe3ddde-691a-4303-bcb2-51d9b48c1fda
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OdneClean
• Version Model Number: A-0006
• Catalog Number: A-0006
• Company DUNS: 775295061
• Company Name: Minitube AB
• Device Count: 100
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	07649988629310 [Primary]
GS1	07649988629327 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211026

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: 2024-06-10
• Device Publish Date: 2024-06-01

Devices Manufactured by Minitube AB

• 07649988629310 - OdneClean: 2024-06-10OdneClean barrier sleeves, 100pcs per box.
• 07649988629310 - OdneClean: 2024-06-10 OdneClean barrier sleeves, 100pcs per box.
• 07350069422835 - VALO™ Barrier Sleeves: 2024-05-09 Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient's tissues, as well as etchant
• 07350069422842 - VALO™ Barrier Sleeves: 2024-05-09 Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient's tissues, as well as etchant
• 07350069422859 - VALO™ Barrier Sleeves: 2024-05-09 Barrier sleeves protect your VALO™ curing light from coming into direct contact with the patient's tissues, as well as etchant
• 07350069420763 - MIXPAC Protective Sleeve: 2022-10-11 MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use application systems to protect the
• 07350069420770 - MIXPAC Protective Sleeve: 2022-10-11 MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use application systems to protect the
• 07350069420787 - MIXPAC Protective Sleeve: 2022-10-11 MIXPAC™ Protective Sleeves provide convenient and effective barrier protection of multi-use application systems to protect the