Primary Device ID | 06944843605760 |
NIH Device Record Key | 51922063-c5c5-4563-923e-9c4c1be7a9ee |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PacDent |
Version Model Number | iRoot Pro Plus |
Company DUNS | 545272577 |
Company Name | Guilin Woodpecker Medical Instrument Co., Ltd. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
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 | true |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06944843605760 [Primary] |
EKX | Handpiece, Direct Drive, Ac-Powered |
Steralize Prior To Use | true |
Device Is Sterile | false |
[06944843605760]
Moist Heat or Steam Sterilization
[06944843605760]
Moist Heat or Steam Sterilization
[06944843605760]
Moist Heat or Steam Sterilization
[06944843605760]
Moist Heat or Steam Sterilization
[06944843605760]
Moist Heat or Steam Sterilization
[06944843605760]
Moist Heat or Steam Sterilization
[06944843605760]
Moist Heat or Steam Sterilization
[06944843605760]
Moist Heat or Steam Sterilization
[06944843605760]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-02 |
Device Publish Date | 2021-08-25 |
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