| Primary Device ID | 10860008457414 |
| NIH Device Record Key | 17251d69-1725-4684-9d71-20cd0bf1645a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SHEFA Block |
| Version Model Number | 1 |
| Company DUNS | 118646521 |
| Company Name | Shefa Solutions 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860008457417 [Primary] |
| GS1 | 10860008457414 [Package] Contains: 00860008457417 Package: Inner Box [50 Units] In Commercial Distribution |
| GS1 | 20860008457411 [Package] Package: Outer Box [5 Units] In Commercial Distribution |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-09 |
| Device Publish Date | 2022-04-29 |
| 00860008457431 - SHEFA Forcep | 2022-05-09 FORCEPS, BIOPSY, NON-ELECTRIC |
| 10860008457414 - SHEFA Block | 2022-05-09 |
| 10860008457414 - SHEFA Block | 2022-05-09 |