FDA.reportPublic FDA data

Mindray

Primary DI
06975122554851
Brand
Mindray
Company
JingFang Precision Medical Device(Shenzhen) Co., Ltd.
Model
NGB-063-DK
Catalog number
11485
Device description
Disposable Needle Guides Kit for general purpose biopsy, contents: Needle guide use with |Mindray|SC6-1GU ultrasound transducers; 20g gel; 14x100cm TPU cover, rubber bands.
Published
2026-06-02
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
16975122554858PackageGS124In Commercial Distribution
06975122554851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697512255485816975122554858
06975122554851069751225548516975122554851

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 Temperature00

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
true
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
06975122554868MindrayNGB-051-DK(17/18G)114862026-06-02
06975122554875MindrayNGB-051-DK(15/16G)114872026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975122554868MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
06975122554875MindrayJingFang Precision Medical Device(Shenzhen) Co., Ltd.OIJ2026-06-02
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