| Primary Device ID | 00841668112151 |
| NIH Device Record Key | e8c3a956-b621-4616-8a83-a5f2392c461b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HONAN BALLOON HEADBAND (NO LATEX) |
| Version Model Number | K 9-8412 |
| Catalog Number | K 9-8412 |
| Company DUNS | 085668598 |
| Company Name | KATENA PRODUCTS, INC. |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com | |
| Phone | (973) 989-1600 |
| globe@katena.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841668112151 [Primary] |
| LCC | Applicator, Ocular Pressure |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-22 |
| 10841668123338 - KATENA | 2026-03-10 ROP Kit |
| 10841668123949 - KATENA | 2026-03-10 Flat Vitrectomy Lens w fixed ring |
| 10841668144463 - KATENA | 2026-03-10 High-Mag RS Lens |
| 10841668144470 - KATENA | 2026-03-10 Wide-Angle Viewing RS Lens |
| 10841668146474 - KATENA | 2026-03-10 Tonometer Prism |
| 10841668146580 - Glaukos | 2026-01-23 IPRISMHF, GONIOPRISM |
| 00841668144268 - Primary Lens Set, 28D, 90D, 3 Mirror | 2024-04-19 |
| 00841668144275 - Primary Lens Set, 28D, 90D, 4 Mirror | 2024-04-19 |