| Primary Device ID | 00858604006351 |
| NIH Device Record Key | 1e325892-da2e-4c23-9136-d97a8a58ebcd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intelligent ICSI Micropipette |
| Version Model Number | IC.4.70.xx.C |
| Company DUNS | 152161337 |
| Company Name | HAMILTON THORNE, 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 | 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 | 00858604006351 [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 | 2020-02-27 |
| Device Publish Date | 2020-02-19 |
| 00858604006313 | Micropipette, ICSI, Feature Type 1, 4.5µm |
| 00858604006351 | Micropipette, ICSI, Feature Type 4, 7.0µm, 2.00mm |
| 00858604006429 | Micropipette, ICSI, Feature Type 4, 5.0µm, 2.00mm |
| 00858604006412 | Micropipette, ICSI, Feature Type 2, 4.5µm, 0.55mm |
| 00858604006405 | Micropipette, ICSI, Feature Type 3, 5.5µm |
| 00858604006399 | Micropipette, ICSI, Feature Type 1, 5.5µm |
| 00858604006382 | Micropipette, ICSI, Feature Type 2, 5.0µm, 0.75mm |
| 00858604006375 | Micropipette, ICSI, Feature Type 3, 5.0µm |
| 00858604006368 | Micropipette, ICSI, Feature Type 1, 5.0µm |
| 00858604006344 | Micropipette, ICSI, Feature Type 5, 4.5µm |
| 00858604006337 | Micropipette, ICSI, Feature Type 2, 4.5µm, 0.75mm |
| 00858604006320 | Micropipette, ICSI, Feature Type 3, 4.5µm |
| 00858604006061 | Micropipette, ICSI, Feature Type 3, 90µm, 1.00mm |