Comfi-Tips

GUDID D248155080

Foam covers for saliva ejector tips

HAGER WORLDWIDE, INC.

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• Primary Device ID: D248155080
• NIH Device Record Key: 45ba29e4-a638-43ec-b70b-5a3d035349df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfi-Tips
• Version Model Number: 15508
• Company DUNS: 009277971
• Company Name: HAGER WORLDWIDE, INC.
• Device Count: 100
• 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

Customer Support Contacts

• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D248155080 [Unit of Use]
HIBCC	D248155081 [Primary]

FDA Product Code

• DYN: Mouthpiece, saliva ejector

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-11-23
• Device Publish Date: 2023-07-13

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• D248222360 - SafeDispense - White: 2024-04-22 Floss Holder/dispenser
• D248222380 - SafeDispense - Dual: 2024-04-22 Floss Holder/dispenser
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• D2484522220 - MetaLIFT Regular Removal Instrument Replacement Part: 2023-12-15 MetaLIFT Crown and Bridge Regular Remover replacement