Cleaning sheath for Ø4mm X 155mm 45° 8300055816

GUDID 04035873069300

cleaning sheath sinuscope

Henke-Sass, Wolf GmbH

Endoscope sheath, reusable
Primary Device ID04035873069300
NIH Device Record Key023afdcb-5c66-4897-a4dc-ccb9d42d201a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCleaning sheath for Ø4mm X 155mm 45°
Version Model Number8300055816
Catalog Number8300055816
Company DUNS317326411
Company NameHenke-Sass, Wolf GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *see IFU
Special Storage Condition, SpecifyBetween 0 and 0 *see IFU
Special Storage Condition, SpecifyBetween 0 and 0 *see IFU
Special Storage Condition, SpecifyBetween 0 and 0 *see IFU
Special Storage Condition, SpecifyBetween 0 and 0 *see IFU
Special Storage Condition, SpecifyBetween 0 and 0 *see IFU
Special Storage Condition, SpecifyBetween 0 and 0 *see IFU
Special Storage Condition, SpecifyBetween 0 and 0 *see IFU
Special Storage Condition, SpecifyBetween 0 and 0 *see IFU
Special Storage Condition, SpecifyBetween 0 and 0 *see IFU
Special Storage Condition, SpecifyBetween 0 and 0 *see IFU

Device Identifiers

Device Issuing AgencyDevice ID
GS104035873069300 [Primary]

FDA Product Code

KMAIrrigator, Powered Nasal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04035873069300]

Moist Heat or Steam Sterilization


[04035873069300]

Moist Heat or Steam Sterilization


[04035873069300]

Moist Heat or Steam Sterilization


[04035873069300]

Moist Heat or Steam Sterilization


[04035873069300]

Moist Heat or Steam Sterilization


[04035873069300]

Moist Heat or Steam Sterilization


[04035873069300]

Moist Heat or Steam Sterilization


[04035873069300]

Moist Heat or Steam Sterilization


[04035873069300]

Moist Heat or Steam Sterilization


[04035873069300]

Moist Heat or Steam Sterilization


[04035873069300]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-05-01

Devices Manufactured by Henke-Sass, Wolf GmbH

04035873013006 - HSW LIGMAJECT® I2024-04-24 HSW LIGMAJECT® I 1,8 ML IMPERIAL THREAD
04035873013020 - HSW LIGMAJECT® II2024-04-24 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 CW2024-04-24 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 SA2024-04-24 HENKE-DENT 3000 SA 1,8 ml Imperial (US) Thread
04035873057093 - HENKE-DENT 500 SOFT-GRIP2024-04-24 HENKE-DENT 500 SOFT-GRIP PETITE ROT US

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.