FDA UDI In Commercial Distribution 🇺🇸 United States

InnoFine

DI: 06971554723421 · Model: JSP-020 · JingFang Precision Medical Device(Shenzhen) Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
InnoFine
Primary DI
06971554723421
Version / Model
JSP-020
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
2020-09-04
Public Version
2
Public Version Date
2022-06-17
Public Version Status
Update
Public Device Record Key
263464fe-ed6e-4fee-8634-27930a2052f3

Device Description

Reusable Needle Guides for use with Wisonic L15-4 Ultrasound Transducers and BARD Needle Guide 900013B01(21G).

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
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
High-level Disinfectant

Product Codes

Code Name
OIJ Biopsy Needle Guide Kit

GMDN Terms

Code Name
60734 Needle guide, reusable

Identifiers

Type ID
Primary 06971554723421