DELTA

Basic Information

• Brand Name: DELTA
• Primary DI: 07613327392715
• Version / Model: 70-76201
• Catalog Number: 70-76201
• Company Name: Stryker Leibinger GmbH & Co. KG
• Labeler DUNS: 316153956
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-07
• Public Version: 3
• Public Version Date: 2022-02-16
• Public Version Status: Update
• Public Device Record Key: 4c4c4e14-98bc-43c1-bc02-be04eb2fea76

Device Description

DELTA WATER BATH 2.0

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IRQ	UNIT, HEATING, POWERED	Physical Medicine	890.5950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47744	Surgical water bath system	An assembly of devices designed for use within the sterile surgical field in an operating room (OR) to heat implants (typically fixation plates and screws) to make them more malleable. The assembly typically consists of a mains electricity (AC-powered) water bath with temperature-regulating controls, a thermometer/thermostats, a timer, a sterilizable water holder (a pan or a tray), and a sterility cover that is placed over the bath to maintain the integrity of the sterile surgical field. The implants are submerged in sterile water or saline solution and typically heated to approximately 60-70? Celsius.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327392715	GS1

Storage Conditions

• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 78.5 – 102 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal
• Type: Storage Environment Humidity
• Temperature Range: 10 – 70 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius