| Primary Device ID | D82795475870 |
| NIH Device Record Key | 11365ad4-a8ad-45ba-b024-19dc45fbab9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FROST ENDO SPRAY |
| Version Model Number | 9547587 |
| Catalog Number | 9547587 |
| Company DUNS | 825137818 |
| Company Name | DARBY DENTAL SUPPLY, LLC |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com | |
| Phone | +1(516)688-6800 |
| Robyn.livingston@darby.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D82795475870 [Primary] |
| EAT | Tester, pulp |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-08-17 |
| 00889813063576 - Darby Dental Supply, LLC | 2024-10-09 RUBBER DAM FRAME 5" |
| 00889813063590 - Darby Dental Supply, LLC | 2024-10-09 CLAMP RUBBER DAM I-V TYPE |
| 00889813063644 - Darby Dental Supply, LLC | 2024-10-09 SCALPEL BLADE HANDLE 4 |
| 00889813063651 - Darby Dental Supply, LLC | 2024-10-09 RETRACTION CORD PACK SERRATE |
| 00889813063781 - Darby Dental Supply, LLC | 2024-10-09 SPATULA CEMENT 5 DE |
| 00889813063859 - Darby Dental Supply, LLC | 2024-10-09 SPATULA PLASTER STIFF 11R 3.5 |
| 00889813063927 - Darby Dental Supply, LLC | 2024-10-09 SHARP STONE CERAMIC MED RED |
| 00889813063965 - Darby Dental Supply, LLC | 2024-10-09 MOUTH GAG CHILD WITH TIPS |