| Primary Device ID | 04035873069317 | 
| NIH Device Record Key | 3b8b5fe2-93b8-480c-8f5c-96402c9b2fa7 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Cleaning Sheath for Ø4mm X 155mm 70° | 
| Version Model Number | 8300055817 | 
| Catalog Number | 8300055817 | 
| Company DUNS | 317326411 | 
| Company Name | Henke-Sass, Wolf GmbH | 
| 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 | 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 | false | 
| OTC Over-The-Counter | false | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Special Storage Condition, Specify | Between 0 and 0 *see IFU | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04035873069317 [Primary] | 
| KMA | Irrigator, Powered Nasal | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[04035873069317]
Moist Heat or Steam Sterilization
[04035873069317]
Moist Heat or Steam Sterilization
[04035873069317]
Moist Heat or Steam Sterilization
[04035873069317]
Moist Heat or Steam Sterilization
[04035873069317]
Moist Heat or Steam Sterilization
[04035873069317]
Moist Heat or Steam Sterilization
[04035873069317]
Moist Heat or Steam Sterilization
[04035873069317]
Moist Heat or Steam Sterilization
[04035873069317]
Moist Heat or Steam Sterilization
[04035873069317]
Moist Heat or Steam Sterilization
[04035873069317]
Moist Heat or Steam Sterilization
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-05-09 | 
| Device Publish Date | 2022-05-01 | 
| 04035873013006 - HSW LIGMAJECT® I | 2024-04-24 HSW LIGMAJECT® I 1,8 ML IMPERIAL THREAD | 
| 04035873013020 - HSW LIGMAJECT® II | 2024-04-24 HSW LIGMAJECT® II 1,8 ML IMPERIAL THREAD | 
| 04035873027195 - HSW HENKE-JECT® | 2024-04-24 HSW HENKE-JECT® 1,8 ML US | 
| 04035873033646 - HSW Cartridge Syringe CW | 2024-04-24 HSW Cartridge Syringe CW 1,8 ML Imperial Thread | 
| 04035873035817 - HSW SOFT-JECT® | 2024-04-24 HSW SOFT-JECT® 1,8 ML US | 
| 04035873035831 - HSW SOFT-JECT® | 2024-04-24 HSW SOFT-JECT® 1,8 ML IMPERIAL (US) THREAD WITH 30° ANGLE-FORMING DISTAL END | 
| 04035873056799 - HENKE-DENT 3000 SA | 2024-04-24 HENKE-DENT 3000 SA 1,8 ml Imperial (US) Thread | 
| 04035873057093 - HENKE-DENT 500 SOFT-GRIP | 2024-04-24 HENKE-DENT 500 SOFT-GRIP PETITE ROT US |