FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIP

GUDID D2483550861

FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIP

HAGER WORLDWIDE, INC.

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• Primary Device ID: D2483550861
• NIH Device Record Key: de8ea2e3-12e1-420f-9bc9-d8fb6a4734a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIP
• Version Model Number: 355086
• Company DUNS: 009277971
• Company Name: HAGER WORLDWIDE, INC.
• Device Count: 1
• 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: false
• Lot Batch: false
• 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	D2483550861 [Primary]

FDA Product Code

• EAY: LIGHT, FIBER OPTIC, DENTAL

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: 2023-05-22
• Device Publish Date: 2023-05-12

Devices Manufactured by HAGER WORLDWIDE, INC.

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• D248222300 - SafeDispense - Silver: 2024-04-22 Floss Holder/dispenser
• D248222310 - Mini SafeDispense: 2024-04-22 Floss Holder/dispenser
• D248222360 - SafeDispense - White: 2024-04-22 Floss Holder/dispenser
• D248222380 - SafeDispense - Dual: 2024-04-22 Floss Holder/dispenser
• D2486054500 - Mirahold Adult: 2024-02-13 Dental Cheek/Lip Retractor
• D2484522210 - MetaLIFT Replacement Handle: 2023-12-15 MetaLIFT Crown and Bridge Remover replacement handle
• D2484522220 - MetaLIFT Regular Removal Instrument Replacement Part: 2023-12-15 MetaLIFT Crown and Bridge Regular Remover replacement