Primary Device ID | 00386040005138 |
NIH Device Record Key | 2b9f3dee-1896-4b83-808f-4f759f6f579b |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GC TEMP ADVANTAGE® |
Version Model Number | 136506 |
Catalog Number | 136506 |
Company DUNS | 005473608 |
Company Name | Gc America Inc. |
Device Count | 15 |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com | |
Phone | +1(708)597-0900 |
customerservice@gcamerica.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00386040005138 [Unit of Use] |
GS1 | 10386040005135 [Primary] |
EMA | CEMENT, DENTAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2022-07-15 |
Device Publish Date | 2022-07-07 |
10386040005142 | GC TEMP ADVANTAGE® Bulk Package (4 x 7.5g syringes) |
00386040005138 | GC TEMP ADVANTAGE® 15 x mixing tips |
10386040005128 | GC TEMP ADVANTAGE® Starter Package (1 x 7.5g syringe and 15 x mixing tips) |