| Primary Device ID | D2482540240 |
| NIH Device Record Key | edb0e669-786a-4735-a693-17a8c51a831c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pelotte Plus Evacuation Tip |
| Version Model Number | 254024 |
| Company DUNS | 009277971 |
| Company Name | HAGER WORLDWIDE, INC. |
| Device Count | 10 |
| 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 | |
| Phone | +1(828)624-3319 |
| d.pritchard@hagerworldwide.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D2482540240 [Unit of Use] |
| HIBCC | D2482540241 [Primary] |
| DYN | Mouthpiece, saliva ejector |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
[D2482540240]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-11-30 |
| Device Publish Date | 2023-09-12 |
| 00014081540249 | 4" plastic dental aspirator tip (green) |
| D2482540240 | 4" plastic dental aspirator tip (green) |