Device
HIP Cleaning Solution with Instrument Protection. For the Hydrim L110/M2.
Manufacturer
Dent4You AG
Dent4You AG
Model: CS-HIPL
Catalog: CS-HIPL
DI: 07640397420406
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-06
Current Version: 2026-05-14
Description
HIP Cleaning Solution with Instrument Protection. For the Hydrim L110/M2.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
6ec1093b-4969-45da-b2c1-0b55d401ce34
Distribution Status:
In Commercial Distribution
DUNS Number:
480152811
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Carton
Item #1 - Device ID:
17640397420403
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
2
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
07640397420406
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07640397420406
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
07540196001090
Item #3 - Device ID Type:
Previous
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 63385
Name: Medical device cleaning agent
Definition:
A substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.
FDA Product Codes
LDS
Device, Pasteurization, Hot Water