| Primary Device ID | 00815212021787 |
| NIH Device Record Key | faedd390-6dfe-4da4-9238-faf65813cf08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Moldcare |
| Version Model Number | MC7004 |
| Company DUNS | 933506164 |
| Company Name | Izi Medical Products, LLC |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00815212021787 [Primary] |
| KXH | Cradle, Patient, Radiologic |
| 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 | 2017-02-03 |
| 00815212021800 | MC7006 |
| 00815212021794 | MC7005 |
| 00815212021787 | MC7004 |
| 00815212021770 | MC7003 |
| 00815212021763 | MC7002 |
| 00815212021756 | MC7001 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MOLDCARE 75572500 2380500 Live/Registered |
ALCARE CO., LTD. 1998-10-19 |