| Primary Device ID | B360011B12632 |
| NIH Device Record Key | d824b709-1cd3-4d50-9299-d37efcff3ade |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Prager Ext Set B1263 |
| Version Model Number | 011B1263 |
| Catalog Number | 011B1263 |
| Company DUNS | 829391734 |
| Company Name | ESI CORPORATION |
| Device Count | 1 |
| 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 | false |
| 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 |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com | |
| Phone | 763-473-2533 |
| sales@eyesurgin.com |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Length | 14 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B360011B12630 [Primary] |
| HIBCC | B360011B12631 [Package] Contains: B360011B12630 Package: BOX [4 Units] In Commercial Distribution |
| HIBCC | B360011B12632 [Package] Contains: B360011B12630 Package: BOX [25 Units] In Commercial Distribution |
| FMG | Stopcock, I.V. Set |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-11 |
| Device Publish Date | 2016-09-24 |
| B360PSVGS0 - PRAGER SHELL® P106SVGS | 2019-12-26 PRAGER SHELL® P106 AUTOCLAVABLE ULTRASOUND IMMERSION SHELL. |
| B360011B12361 - Prager Ext Set A1236 | 2019-12-11 Replacement Part |
| B360011B12632 - Prager Ext Set B1263 | 2019-12-11Replacement Part |
| B360011B12632 - Prager Ext Set B1263 | 2019-12-11 Replacement Part |
| B360KF100 - Kera-Flow | 2019-09-18 Eye Irrigation Device |
| B360CS2001 - ClearScan® | 2018-07-06 ClearScan |
| B360P1000 - Prager Shell® | 2018-07-06 Accutome / MicroMedical |
| B360P100AS0 - Prager Shell® | 2018-07-06 Accutome Probe, Auto Stop |
| B360P1010 - Prager Shell® | 2018-07-06 For DGH 2009 and earlier |