| Primary Device ID | 00841668112168 |
| NIH Device Record Key | f1dc494f-405b-4a81-a5dc-cb1f5a84dd50 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SCHIOTZ TONOMETER |
| Version Model Number | K 9-8500 |
| Catalog Number | K 9-8500 |
| Company DUNS | 085668598 |
| Company Name | KATENA PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841668112168 [Primary] |
| HKY | Tonometer, Manual |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00841668112168]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-10-28 |
| Device Publish Date | 2016-09-22 |
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| 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 |
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| 00841668144275 - Primary Lens Set, 28D, 90D, 4 Mirror | 2024-04-19 |