ALMORE BITE REGISTRATION SHEETS

GUDID D248426000

BITE REGISTRATION SHEETS

HAGER WORLDWIDE, INC.

Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax Bite registration rim wax

• Primary Device ID: D248426000
• NIH Device Record Key: 73bb2d2b-6829-4542-92d2-da062bcd2778
• Commercial Distribution Discontinuation: 2023-08-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: ALMORE BITE REGISTRATION SHEETS
• Version Model Number: 42600
• Company DUNS: 009277971
• Company Name: HAGER WORLDWIDE, INC.
• Device Count: 1
• DM Exempt: true
• 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: 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
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D248426000 [Primary]

FDA Product Code

• EGD: WAX, DENTAL, INTRAORAL

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: 2023-09-13
• Device Publish Date: 2022-12-08

Devices Manufactured by HAGER WORLDWIDE, INC.

• D2483553190 - Plast Frame: 2024-04-24 Rubber dam frame
• 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