FDA.report

CAPO Needle

Primary DI
08800046101080
Brand
CAPO Needle
Company
NEXONE BIO CO., LTD.
Model
NOR-VPNL11SB
Published
2024-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
OCJSpinal Channeling Instrument, Vertebroplasty

Product Code Classifications

CodeDeviceSpecialtyClass
OCJSpinal Channeling Instrument, VertebroplastyOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800046101080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800046101080088000461010808800046101080

GMDN Terms

TermDefinition
Bone access cannulaA sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
693705461
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 DIBrandModelCatalogPublished
08800046100380CAPO NeedleNOB-VPU11SB2024-10-29
08800046101202CAPO NeedleNOB-VPNL10D2024-10-29
08800046100427CAPO NeedleNOB-VPU11D2024-05-08
08800046101066CAPO NeedleNOR-OSK095D2024-05-08

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00815212026973BLAZER-C CURVED INJECTION SYSTEM-MVIzi Medical Products, LLCOCJ2025-05-21
B90829211908Main-AXS Needle-RetropsoasMainstream Medical Devices, LLCOCJ2025-04-30
08053175016125Vertebroplasty NeedleADRIA SRLOCJ2025-04-07
B908350008000Main-AXS Needle-Spinal SimplicityMainstream Medical Devices, LLCOCJ2024-12-03
B908350009000Main-AXS Needle-Spinal SimplicityMainstream Medical Devices, LLCOCJ2024-12-03
08800046100380CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
08800046101202CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-10-29
08058964724687V-AccessG21 SRLOCJ2024-10-16
08058964725356V-AccessG21 SRLOCJ2024-10-16
08058964725363V-AccessG21 SRLOCJ2024-10-16
08058964725417V-AccessG21 SRLOCJ2024-10-16
08058964724021KeyFix Direct Access NeedleG21 SRLOCJ2024-10-10
08058964724052KeyFix Bone Cement Filler CannulaG21 SRLOCJ2024-10-10
08058964724083KeyFix Bone Cement Filler CannulaG21 SRLOCJ2024-10-10
08058964724113KeyFix Direct Access NeedleG21 SRLOCJ2024-10-10
08058964725431V-AccessG21 SRLOCJ2024-10-10
08058964725448V-AccessG21 SRLOCJ2024-10-10
08058964727725Keyfix direct access needle 8GG21 SRLOCJ2024-10-10
08058964727732Keyfix Bone Cement Filler Cannula 9GG21 SRLOCJ2024-10-10
08800046100427CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-05-08
08800046101066CAPO NeedleNEXONE BIO CO., LTD.OCJ2024-05-08
08033860043643BIOPSYBELLBIOPSYBELL SRLOCJ2024-02-23
08033860025632BIOPSYBELLBIOPSYBELL SRLOCJ2024-02-23
08033860043650BIOPSYBELLBIOPSYBELL SRLOCJ2024-02-23
03760177045743Vertebroplasty needlesTEKNIMEDOCJ2023-09-06
03760177045767Vertebroplasty needlesTEKNIMEDOCJ2023-09-06
08033860019365BIOPSYBELLBIOPSYBELL SRLOCJ2023-08-28
08033860022310BIOPSYBELLBIOPSYBELL SRLOCJ2023-08-28
00850054612199MedioxMediox Medical Service LtdOCJ2023-08-17
08033860029166BIOPSYBELLBIOPSYBELL SRLOCJ2023-06-26