InnoFine

Basic Information

• Brand Name: InnoFine
• Primary DI: 06971554725128
• Version / Model: DE-012
• Catalog Number: DE-012
• Company Name: JingFang Precision Medical Device(Shenzhen) Co., Ltd.
• Labeler DUNS: 544571975
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-27
• Public Version: 5
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: 21b5befe-e5a5-463d-91b5-228bb1f50728

Device Description

Disposable Needle Guides for use with Samsung ER4-9/10ED, EV4-9/10ED, EVN4-9, ER4-9; Ultrasonix EC9-5/10; Alpinion EN3-10; ECM E610R Ultrasound Transducers

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OIJ	Biopsy Needle Guide Kit	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45018	Needle guide, single-use	A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	16971554725125	GS1		24	In Commercial Distribution
Primary	06971554725128	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Away from Sunlight