Primary Device ID | D2482541500 |
NIH Device Record Key | c84db43c-2169-4b45-86d9-025bae296dba |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Swe-Flex |
Version Model Number | 254150 |
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 | 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 | |
Phone | +1(828)624-3319 |
d.pritchard@hagerworldwide.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | D2482541500 [Unit of Use] |
HIBCC | D2482541501 [Primary] |
DYN | Mouthpiece, saliva ejector |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-11-29 |
Device Publish Date | 2023-07-13 |
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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 |