FDA.report

InnoFine

Primary DI
06971554720123
Brand
InnoFine
Company
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
Model
JSM-010
Device description
Reusable Needle Guides for use with GE Healthcare 11L, 12L, 11L-D, 12L-RS, 12L-SC, L6-12-RS; L4-12t-RS, L12n-RS, L12n-SC Ultrasound Transducers
Published
2025-02-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OIJBiopsy Needle Guide Kit

Product Code Classifications

CodeDeviceSpecialtyClass
OIJBiopsy Needle Guide KitRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06971554720123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06971554720123069715547201236971554720123

GMDN Terms

TermDefinition
Needle guide, reusableA 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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
544571975
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
16975122553660mindrayDGCK-0101-M113662025-07-25
16975122553684mindrayDGK-A01-M113682025-07-25
16975122553707mindrayDGCK-1101-M113702025-07-25
16971554726597InnoFineDGCK-01106592025-05-08
16971554726870InnoFineDGK-A01106872025-05-08
06971554726989MindrayNGB-043-D106982025-05-08
06971554727283MindrayNGB-044-D107282025-05-08
06971554727306MindrayNGB-054-D107302025-05-08
06971554727320MindrayNGB-057-D107322025-05-08
06971554727344MindrayNGB-058-D107342025-05-08
06975122551096InnoFineDGCK-0101111092025-05-08
16975122551130InnoFineDGCK-0102111132025-05-08
16975122553004InnoFineDGCK-1101113002025-05-08
06975122553014MindrayNGB-060-D113012025-05-08
06975122553021MindrayNGB-066-D113022025-05-08
06975122553038MindrayNGB-067-D113032025-05-08
06975122553045MindrayNGB-062-D113042025-05-08
06975122553649MindrayNGB-062-DK113642025-05-08
16975122553721InnoFineDGCK-11113722025-05-08
16975122553745InnoFineDGCK-1102113742025-05-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50198956075359CARDINAL HEALTHCardinal Health 200, LLCOIJ2025-08-11
16975122553660mindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-07-25
16975122553684mindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-07-25
16975122553707mindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-07-25
50197106788552CARDINAL HEALTHCardinal Health 200, LLCOIJ2025-06-05
16971554726597InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16971554726870InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06971554726989MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06971554727283MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06971554727306MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06971554727320MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06971554727344MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122551096InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16975122551130InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16975122553004InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122553014MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122553021MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122553038MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122553045MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
06975122553649MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16975122553721InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16975122553745InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
16975122558627InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-05-08
50198956069990CARDINAL HEALTHCardinal Health 200, LLCOIJ2025-05-07
00628055481225EV29L Non-Sterile Reusable PrecisionPoint AdapterExact Imaging IncOIJ2025-05-05
06971554721830InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-04-01
06971554727825InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-04-01
06971554727832InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-04-01
06971554728006InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-04-01
06971554728013InnoFineJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2025-04-01