| Primary Device ID | 00850068289059 |
| NIH Device Record Key | d39dffe1-497e-444e-9d99-d3e8a7ccb1bb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SFG Denuding pipettes |
| Version Model Number | S-P-D180 |
| Company DUNS | 119292307 |
| Company Name | SPECTRUM FERTILITY GROUP INC. |
| Device Count | 10 |
| 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 | 00850068289059 [Unit of Use] |
| GS1 | 10850068289056 [Primary] |
| PUC | Microtools, Assisted Reproduction (Pipettes), 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 |
| 00850068289110 | S-P-D290 |
| 00850068289103 | S-P-D270 |
| 00850068289097 | S-P-D250 |
| 00850068289080 | S-P-D230 |
| 00850068289073 | S-P-D210 |
| 00850068289066 | S-P-D190 |
| 00850068289059 | S-P-D180 |
| 00850068289042 | S-P-D170 |
| 00850068289035 | S-P-D160 |
| 00850068289028 | S-P-D150 |
| 00850068289011 | S-P-D140 |
| 00850068289004 | S-P-D130 |