Primary Device ID | E29968919 |
NIH Device Record Key | c9282e8a-25d2-414b-ab19-c5c1d0c681f6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | myRing Prime |
Version Model Number | 6891 |
Catalog Number | 6891 |
Company DUNS | 481461598 |
Company Name | Polydentia SA |
Device Count | 2 |
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 | true |
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 |
Device Issuing Agency | Device ID |
---|---|
HIBCC | E29968910 [Primary] |
HIBCC | E29968919 [Unit of Use] |
DZN | Instruments, Dental Hand |
Steralize Prior To Use | true |
Device Is Sterile | false |
[E29968919]
Moist Heat or Steam Sterilization
[E29968919]
Moist Heat or Steam Sterilization
[E29968919]
Moist Heat or Steam Sterilization
[E29968919]
Moist Heat or Steam Sterilization
[E29968919]
Moist Heat or Steam Sterilization
[E29968919]
Moist Heat or Steam Sterilization
[E29968919]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-06-24 |
Device Publish Date | 2025-06-16 |
E29950029 - wood wedges | 2025-06-24 |
E2995018MN9 - Orange wood wedges | 2025-06-24 |
E2995018PLUS9 - Orange wood wedges | 2025-06-24 |
E2995018S9 - Orange wood wedges | 2025-06-24 |
E29968900 - myQuickmat Prime Kit | 2025-06-24 |
E29968919 - myRing Prime | 2025-06-24 |
E29968919 - myRing Prime | 2025-06-24 |
E29968929 - myTines Prime | 2025-06-24 |
E29968939 - Quickmat Prime | 2025-06-24 |