| Primary Device ID | 04058935000561 |
| NIH Device Record Key | 8aa992b5-5d15-4852-9936-db3676c03425 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BIPOL.PEN 25G LEMO BLUNT 12BX |
| Version Model Number | E7927 |
| Catalog Number | E7927 |
| Company DUNS | 342397433 |
| Company Name | Bausch & Lomb GmbH |
| Device Count | 12 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04058935000561 [Primary] |
| GS1 | 24058935000565 [Unit of Use] |
| GXI | Probe, Radiofrequency Lesion |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-29 |
| Device Publish Date | 2016-07-15 |
| 04058935000646 - PPT MICS 6/BX | 2019-11-08 Single Use Medical Device for Ophthalmic Surgery |
| 04058935000653 - PPT CRYSTALENS 12/BX | 2019-11-08 Single Use Medical Device for Ophthalmic Surgery |
| 04058935000011 - SIL I/A HANDP CURVED STELL 12/B | 2019-10-07 Single Use Medical Device for Ophthalmic Surgery |
| 04058935000028 - ASP HANDPIECE STERILE 12/BOX | 2019-10-07 Single Use Medical Device for Ophthalmic Surgery |
| 04058935000035 - IRR HANDPIECE STERILE 12/BOX | 2019-10-07 Single Use Medical Device for Ophthalmic Surgery |
| 04058935000042 - I/A HANDP.STRAIGHT,17G 12/BOX | 2019-10-07 Single Use Medical Device for Ophthalmic Surgery |
| 04058935000059 - I/A HANDP.CURVED,17G 12/BOX | 2019-10-07 Single Use Medical Device for Ophthalmic Surgery |
| 04058935000066 - I/A HANDPIECE CURVED 17G 12/B | 2019-10-07 Single Use Medical Device for Ophthalmic Surgery |