FDA.reportPublic FDA data

InnoFine

Primary DI
16971554726825
Brand
InnoFine
Company
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
Model
DE-030
Catalog number
10682
Device description
Disposable Needle Guides for use with BK 8808e, 8818, E14C4t, 9018, E11C3b, 9008 Ultrasound Transducers
Published
2025-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OIJBiopsy Needle Guide Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIJBiopsy Needle Guide KitRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971554726825PackageGS124In Commercial Distribution
06971554726828PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697155472682516971554726825
06971554726828069715547268286971554726828

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away from Sunlight
Storage Environment Temperature50 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+8675527597952Sales@innofine.cn

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
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
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