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 |