Primary Device ID | D2483550881 |
NIH Device Record Key | 6850d309-e093-417f-8093-18f166df3d93 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FOCU-TIP NO.9 (SET/2) WHITE LIGHT INTENSIFYING TIP |
Version Model Number | 355088 |
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 |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D2483550881 [Primary] |
EAY | LIGHT, FIBER OPTIC, DENTAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-05-22 |
Device Publish Date | 2023-05-12 |
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 |