N/A

Basic Information

• Brand Name: N/A
• Primary DI: 07613327482676
• Version / Model: 9126130000
• Catalog Number: 9126-130-000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-13
• Public Version: 1
• Public Version Date: 2021-07-21
• Public Version Status: New
• Public Device Record Key: e495d794-26a8-499c-87fb-5c9356ce406c

Device Description

System 9 Transfer Shield, Large

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: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HWE	INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47867	Surgical power tool battery-exchange sterility cover	A cover that functions as a physical barrier between a battery and the sterile battery-powered surgical power tool (e.g., a drill or saw) in which the non-sterile battery is being placed/exchanged prior to or during a surgical procedure. It is typically made from high-grade stainless steel and/or synthetic material and is designed as a flange that fits into/around the slot where the battery is housed (typically in the handle of the power tool). This ensures that no contact is made between the sterile power tool and the person holding it inside the sterile operation field and the non-sterile battery and person loading the battery from outside the sterile field. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07613327482676	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal
• Type: Handling Environment Temperature
• Temperature Range: -20 – 40 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 75 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 50 – 106 KiloPascal