| Primary Device ID | 04035873069447 |
| NIH Device Record Key | 2cc9395c-d216-4734-857d-f04790ac9d02 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cleaning sheath for Ø3.1mm X 170mm 70° R |
| Version Model Number | 8300052778 |
| Catalog Number | 8300052778 |
| 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 | 04035873069447 [Primary] |
| KMA | Irrigator, Powered Nasal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04035873069447]
Moist Heat or Steam Sterilization
[04035873069447]
Moist Heat or Steam Sterilization
[04035873069447]
Moist Heat or Steam Sterilization
[04035873069447]
Moist Heat or Steam Sterilization
[04035873069447]
Moist Heat or Steam Sterilization
[04035873069447]
Moist Heat or Steam Sterilization
[04035873069447]
Moist Heat or Steam Sterilization
[04035873069447]
Moist Heat or Steam Sterilization
[04035873069447]
Moist Heat or Steam Sterilization
[04035873069447]
Moist Heat or Steam Sterilization
[04035873069447]
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 |