AccessGUDID - DEVICE: InnoFine (06971554720017)

GUDID

Device Identifier (DI) Information

Brand Name: InnoFine
Version or Model: JEM-028
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JingFang Precision Medical Device(Shenzhen) Co., Ltd.

Primary DI Number: 06971554720017
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544571975 *Terms of Use

Device Description: Reusable Needle Guides for use with Mindray 65EC10(EA,EB,EC,ED,HA),6CV1(s,P),CB10-4(s,P,E,A),V10-4(s),V10-4B(s,P),V11-3(E,s),V11-3B(E),V11-3W(s,E),E9-3,V11-3H(E,U,s); Lanmage EC4-9(Y),EC3-11; VINNO G4-9E; Zoncare 6E1CD; Hisense E9-4B,E9-4E; Krinwave EC5(v); COMEN E3-11H; Wisonic EV10-4, EV11-3-H; Esaote E8-5; ULTRAST R10H6 Ultrasound Transducers

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60734	Needle guide, reusable	A non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OIJ	Biopsy Needle Guide Kit

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 02808c45-6563-4504-a60e-a6dcfbf640b5
Public Version Date: February 12, 2025
Public Version Number: 4
DI Record Publish Date: September 04, 2020