| Primary Device ID | 20818524020367 |
| NIH Device Record Key | 65707ce4-37db-4b90-a0c9-74a0432dd16a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | IMPRESS-RITE |
| Version Model Number | IMP-9005 |
| Catalog Number | IMP-9005 |
| Company DUNS | 030479000 |
| Company Name | CROWN DELTA CORPORATION |
| Device Count | 1 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00818524020363 [Primary] |
| GS1 | 10818524020360 [Package] Contains: 00818524020363 Package: KIT [4 Units] In Commercial Distribution |
| GS1 | 20818524020367 [Package] Contains: 10818524020360 Package: CASE [10 Units] In Commercial Distribution |
| ELW | Material, Impression |
| 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 | 2017-07-05 |
| 10818524020674 | M&S DENTAL IMPRESS-RITE SHM HEAVY BODY FAST SET - 50 mL CARTRIDGE |
| 00818524020639 | M&S DENTAL IMPRESS-RITE HP TEMPORARY CEMENT MIXING TIP 20 PER BAG |
| 10818524020599 | M&S DENTAL IMPRESS-RITE SHM LIGHT BODY REGULAR SET - 50 mL CART |
| 10818524020575 | M&S DENTAL IMPRESS-RITE SHM HEAVY BODY REGULAR SET - 50 mL CART |
| 00818524020431 | M&S DENTAL IMPRESS-RITE SHM MEDIUM BODY TUBE KIT |
| 00818524020424 | M&S DENTAL IMPRESS-RITE PUTTY KIT 50D FAST SET |
| 10818524020407 | M&S DENTAL IMPRESS-RITE SHM LIGHT BODY TUBE KIT |
| 00818524020394 | M&S DENTAL IMPRESS-RITE PUTTY KIT 50D REGULAR SET |
| 10818524020384 | M&S DENTAL IMPRESS-RITE SHM HEAVY BODY REGULAR SET TUBE KIT |
| 20818524020367 | M&S DENTAL IMPRESS-RITE SHM MONOPHASE REGULAR SET - 50 mL CART |
| 20818524020343 | M&S DENTAL IMPRESS-RITE SHM LIGHT BODY FAST SET - 50 mL CART |
| 20818524020336 | M&S DENTAL IMPRESS-RITE SHM LIGHT BODY REGULAR SET - 50 mL CART |
| 10818524020322 | M&S DENTAL IMPRESS-RITE SHM MONOPHASE TUBE KIT |
| 20818524020305 | M&S DENTAL IMPRESS-RITE SHM MONOPHASE FAST SET - 50 mL CART |
| 20818524020268 | M&S DENTAL IMPRESS-RITE SHM MONOPHASE REGULAR SET - 50 mL CART |
| 20818524020237 | M&S DENTAL IMPRESS-RITE SHM MEDIUM BODY REGULAR SET - 50 mL CART |
| 20818524020220 | M&S DENTAL IMPRESS-RITE SHM MEDIUM BODY FAST SET - 50 mL CART |
| 20818524020183 | M&S DENTAL IMPRESS-RITE SHM HEAVY BODY FAST SET 50 mL CART |
| 10818524020629 | M&S DENTAL IMPRESS-RITE 380 HEAVY BODY REGULAR SET |