FDA.reportPublic FDA data

Mindray

Primary DI
06975122553045
Brand
Mindray
Company
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
Model
NGB-062-D
Catalog number
11304
Device description
Disposable Needle Guides for use with Mindray SV10-2U Ultrasound Transducers
Published
2025-05-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
16975122553042PackageGS124In Commercial Distribution
06975122553045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697512255304216975122553042
06975122553045069751225530456975122553045

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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975122553663mindrayDGCK-0101-M113662025-07-25
06975122553687mindrayDGK-A01-M113682025-07-25
06975122553700mindrayDGCK-1101-M113702025-07-25
16975122553660mindrayDGCK-0101-M113662025-07-25
16975122553684mindrayDGK-A01-M113682025-07-25
16975122553707mindrayDGCK-1101-M113702025-07-25
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
06975122553014MindrayNGB-060-D113012025-05-08
06975122553021MindrayNGB-066-D113022025-05-08
06975122553038MindrayNGB-067-D113032025-05-08
06971554726590InnoFineDGCK-01106592025-05-08
06971554726873InnoFineDGK-A01106872025-05-08
06975122551133InnoFineDGCK-0102111132025-05-08
06975122553007InnoFineDGCK-1101113002025-05-08
06975122553724InnoFineDGCK-11113722025-05-08
06975122553748InnoFineDGCK-1102113742025-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B201CGSG140Clear Guide SteriGRIDCLEAR GUIDE MEDICAL, INC.OIJ2026-05-11
06945868600471SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603809SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603816SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603823SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603830SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603847SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868603878SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605872SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605889SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605896SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605902SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605919SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605926SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605933SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605940SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605957SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605964SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605971SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605988SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868605995SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606008SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606015SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606022SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606039SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606046SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606053SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606060SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606077SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09
06945868606084SonoScapeSONOSCAPE MEDICAL CORP.OIJ2025-10-09