Primary Device ID | 00615375001721 |
NIH Device Record Key | f5824f15-034a-4f51-90f5-1948590c1bd9 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | EndoraGard |
Version Model Number | 29520DX |
Company DUNS | 199354556 |
Company Name | Kerr Corporation |
Device Count | 50 |
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 | true |
OTC Over-The-Counter | false |
Phone | +18005377123 |
customercare@kavokerrgroup.com | |
Phone | +18005377123 |
customercare@kavokerrgroup.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00615375001721 [Primary] |
GS1 | 00615375008409 [Unit of Use] |
BRW | PROTECTOR, DENTAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2017-08-31 |
00195062037979 - Rubber Base Adhesive | 2024-11-04 Impression adhesive for Permlastic. |
00841396118630 - Permlastic | 2024-11-04 Impression material base, regular bodied |
00841396118647 - Permlastic | 2024-11-04 Impression material catalyst, regular bodied |
00841396118654 - Permlastic | 2024-11-04 Impression material base, heavy bodied |
00841396118661 - Permlastic | 2024-11-04 Impression material catalyst, heavy bodied |
00841396118678 - Permlastic | 2024-11-04 Impression material base, light bodied |
00841396118685 - Permlastic | 2024-11-04 Impression material catalyst, light bodied |
00841396118708 - Permlastic | 2024-11-04 Impression material, standard package, heavy bodied (base and catalyst) |