Primary Device ID | J015504000110 |
NIH Device Record Key | bd06e880-cf45-448b-acbb-7de9047024c6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ENDO 1500 MID MEDI |
Version Model Number | MID |
Catalog Number | 50400011 |
Company DUNS | 276075371 |
Company Name | MICRO MEGA |
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 | true |
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 |
---|---|
HIBCC | J015504000110 [Primary] |
HIBCC | J015504000111 [Direct Marking] |
ELC | Scaler, Ultrasonic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[J015504000110]
Moist Heat or Steam Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-06-13 |
Device Publish Date | 2016-09-22 |
23701310322684 - EdgeOne-R Utopia R-Glide | 2024-04-16 Endodontic instrument for professional dental use only |
23701310322691 - EdgeOne-R Utopia R-Glide | 2024-04-16 Endodontic instrument for professional dental use only |
23701310322707 - EdgeOne-R Utopia R-Glide | 2024-04-16 Endodontic instrument for professional dental use only |
23701310322745 - EdgeOne-R Utopia | 2024-04-16 Endodontic instrument for professional dental use only |
23701310322752 - EdgeOne-R Utopia | 2024-04-16 Endodontic instrument for professional dental use only |
23701310322769 - EdgeOne-R Utopia | 2024-04-16 Endodontic instrument for professional dental use only |
23701310322776 - EdgeOne-R Utopia | 2024-04-16 Endodontic instrument for professional dental use only |
23701310322783 - EdgeOne-R Utopia | 2024-04-16 Endodontic instrument for professional dental use only |