H.V.E. LEVER, GRAY (3/PK)

GUDID D248B111130

HVE Replacement Levers (3/pk)

HAGER WORLDWIDE, INC.

Dental suction system

• Primary Device ID: D248B111130
• NIH Device Record Key: 8996e3b8-1eed-4ba5-9cbd-ac4caa256268
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: H.V.E. LEVER, GRAY (3/PK)
• Version Model Number: B11113
• Company DUNS: 009277971
• Company Name: HAGER WORLDWIDE, INC.
• Device Count: 3
• 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
• Phone: +1(828)624-3319
• Email: d.pritchard@hagerworldwide.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D248B111130 [Unit of Use]
HIBCC	D248B111131 [Primary]

FDA Product Code

• EAX: MIRROR, MOUTH

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: 2023-08-24
• Device Publish Date: 2023-08-16

Devices Manufactured by HAGER WORLDWIDE, INC.

• D2486300620 - TS1 Tongue Vacuum Cleaner: 2024-08-28 Tongue scraper
• D2483552470 - The Prepster (also known as LaminateButler): 2024-07-23 Chairside organizer for dental restorative cases
• D2483552520 - BurButler ( 5 Hole Orange Base w/Lid): 2024-07-23 Dental bur holder
• D2483552530 - BurButler ( 10 Hole White Base w/Lid): 2024-07-23 Dental bur holder
• D2483552540 - BurButler ( 10 Hole Pink Base w/Lid): 2024-07-23 Dental bur holder
• D2483552560 - BurButler ( 10 Hole Blue Base w/Lid): 2024-07-23 Dental bur holder
• D2483552600 - BurButler ( 25 Hole Pink Base w/Lid): 2024-07-23 Dental bur holder
• D2483552620 - BurButler ( 25 Hole Blue Base w/Lid): 2024-07-23 Dental bur holder