Primary Device ID | 00810120870960 |
NIH Device Record Key | 18a4ecb8-4058-43d1-8b14-842e16ce7acb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Acero Crowns ES - Light |
Version Model Number | ESL G1 |
Company DUNS | 006672536 |
Company Name | Park - Istre, LLC |
Device Count | 1 |
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 | 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 |
---|---|
GS1 | 00810120870960 [Primary] |
ELZ | Crown, Preformed |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-11-07 |
Device Publish Date | 2022-10-30 |
00810120871073 | ESL U6 |
00810120871066 | ESL U5 |
00810120871059 | ESL U4 |
00810120871042 | ESL U3 |
00810120871035 | ESL U2 |
00810120871028 | ESL U1 |
00810120871011 | ESL G6 |
00810120871004 | ESL G5 |
00810120870991 | ESL G4 |
00810120870984 | ESL G3 |
00810120870977 | ESL G2 |
00810120870960 | ESL G1 |
00810120870953 | ESL F6 |
00810120870946 | ESL F5 |
00810120870939 | ESL F4 |
00810120870922 | ESL F3 |
00810120870915 | ESL F2 |
00810120870908 | ESL F1 |
00810120870892 | ESL E6 |
00810120870885 | ESL E5 |
00810120870878 | ESL E4 |
00810120870861 | ESL E3 |
00810120870854 | ESL E2 |
00810120870847 | ESL E1 |
00810120870830 | ESL D6 |
00810120870823 | ESL D5 |
00810120870816 | ESL D4 |
00810120870809 | ESL D3 |
00810120870793 | ESL D2 |
00810120870786 | ESL D1 |