EZ-Swivel EZ-Swivel K M4

GUDID 00990010301412

EZ-Swivel K M4, 4 Holes

Beyes Dental Canada Inc

Pneumatic dental handpiece coupler

• Primary Device ID: 00990010301412
• NIH Device Record Key: 42632a00-4568-4ae1-80cb-c18cb7a128b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZ-Swivel
• Version Model Number: HP2063
• Catalog Number: EZ-Swivel K M4
• Company DUNS: 244261462
• Company Name: Beyes Dental Canada Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• 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	00990010301412 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101551

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

[00990010301412]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-19
• Device Publish Date: 2023-05-11

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• 00837699000239: EZ-Swivel K E6, 6 Holes
• 00837699000222: EZ-Swivel K M4, 4 Holes
• 00990010302396: EZ-Swivel N M4, NSK Non Optic, 4 Holes
• 00990010301610: EZ-Swivel PD M4, 4 Holes
• 00990010301603: EZ-Swivel PD B2, 2 Holes
• 00990010301481: EZ-Swivel QD B2, 2 Holes
• 00990010301474: EZ-Swivel QD M4, 4 Holes
• 00990010301429: EZ-Swivel K E6, 6 Holes
• 00990010301412: EZ-Swivel K M4, 4 Holes
• 00990010306455: EZ-Swivel N E6, Coupler E6, 6 Holes, Optic