| Primary Device ID | 00850068289479 |
| NIH Device Record Key | 70bb24f2-7170-4c31-821d-dcb60cd4ba58 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SFG ICSI dish |
| Version Model Number | S-D-50 |
| Company DUNS | 119292307 |
| Company Name | SPECTRUM FERTILITY GROUP INC. |
| Device Count | 500 |
| 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 | true |
| 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 | 00850068289479 [Unit of Use] |
| GS1 | 10850068289476 [Primary] |
| PUD | Labware, Assisted Reproduction, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-20 |
| Device Publish Date | 2024-11-12 |
| 00850068289004 - SFG Denuding pipettes | 2024-11-20 |
| 00850068289011 - SFG Denuding pipettes | 2024-11-20 |
| 00850068289028 - SFG Denuding pipettes | 2024-11-20 |
| 00850068289035 - SFG Denuding pipettes | 2024-11-20 |
| 00850068289042 - SFG Denuding pipettes | 2024-11-20 |
| 00850068289059 - SFG Denuding pipettes | 2024-11-20 |
| 00850068289066 - SFG Denuding pipettes | 2024-11-20 |
| 00850068289073 - SFG Denuding pipettes | 2024-11-20 |