| Primary Device ID | 00853383006202 |
| NIH Device Record Key | 89fa81f5-3a17-4632-afde-c1ade8f5ffdf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Original D Capsules 2 Spill Fast Set 100 count |
| Version Model Number | 61240-03 |
| Company DUNS | 614557155 |
| Company Name | Wykle Research, Inc |
| 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 | true |
| 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 Celsius and 28 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853383006202 [Primary] |
| OIV | Dental Amalgam |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-12 |
| Device Publish Date | 2016-09-23 |
| 00853383006011 - Original D Capsules 1 Spill Fast Set 50 count | 2018-07-12 |
| 00853383006158 - Original D Tablets Fast Set 10 oz | 2018-07-12 |
| 00853383006202 - Original D Capsules 2 Spill Fast Set 100 count | 2018-07-12 |
| 00853383006202 - Original D Capsules 2 Spill Fast Set 100 count | 2018-07-12 |
| 00853383006035 - Wykalloy Capsules 1 Spill 50 count | 2018-07-06 |
| 00853383006042 - Wykalloy Capsules 2 Spill 50 count | 2018-07-06 |
| 00853383006059 - Wykalloy Capsules 3 Spill 50 count | 2018-07-06 |
| 00853383006066 - Wykalloy Capsules 1 Spill 500 count | 2018-07-06 |
| 00853383006073 - Wykalloy Capsules 2 Spill 500 count | 2018-07-06 |