FDA.reportPublic FDA data

K-BALL

Primary DI
03701313007942
Brand
K-BALL
Company
S.M.A.I.O
Model
01BK0001
Catalog number
01BK0001
Device description
K-BALL
Published
2023-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JACSystem, X-Ray, Film Marking, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JACSystem, X-Ray, Film Marking, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701313007942PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701313007942037013130079423701313007942

GMDN Terms#

Term, Definition table
TermDefinition
CT phantom, test objectA device that consist of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions that comes in both fixed and variable configurations. It is a quality assurance (QA) device used in both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic x-ray computed tomography (CT) imaging systems and associated image acquisition, display, and analysis computer programs.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+33469842302contact@smaio.com

Regulatory Flags#

DUNS number
260585710
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701313005177KHEIRON29TC6030229TC603022024-06-24
03701313005184KHEIRON29TC6030129TC603012024-06-24
03701313005191KHEIRON29TC6020229TC602022024-06-24
03701313005207KHEIRON29TC6020129TC602012024-06-24
03701313005214KHEIRON29TC6010229TC601022024-06-24
03701313005221KHEIRON29TC6010129TC601012024-06-24
03701313005238KHEIRON29TC5530229TC553022024-06-24
03701313005245KHEIRON29TC5530129TC553012024-06-24
03701313005252KHEIRON29TC5520229TC552022024-06-24
03701313005269KHEIRON29TC5520129TC552012024-06-24
03701313005276KHEIRON29TC5510229TC551022024-06-24
03701313005283KHEIRON29TC5510129TC551012024-06-24
03701313000028KHEIRON24TS0293124TS029312020-12-14
03701313000035KHEIRON24TS0313524TS031352020-12-14
03701313000042KHEIRON24TS0354324TS035432020-12-14
03701313000073KHEIRON24CR5541524CR554152020-12-14
03701313000080KHEIRON24CR5561524CR556152020-12-14
03701313000097KHEIRON24CR5591524CR559152020-12-14
03701313000103KHEIRON24CR5540524CR554052020-12-14
03701313000110KHEIRON24CR5560524CR556052020-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800ZBAC6305RAY0Printer Resin X-Ray Temporary (500g)ZIRKONZAHN SRLJAC2026-05-20
30815112021505E-Z-MarkBracco Diagnostics Inc.JAC2026-01-09
00816589021219Fiducial Marker, SterileMONTERIS MEDICAL INCJAC2025-02-07
B201CGPAT0Clear Guide TP Access ToolCLEAR GUIDE MEDICAL, INC.JAC2025-01-10
B201CGTPF0Clear Guide TP Access FrameCLEAR GUIDE MEDICAL, INC.JAC2025-01-10
00815137022265RT-SPOTBeekley CorporationJAC2024-08-29
00815137022272RT-SPOTBeekley CorporationJAC2024-08-29
00815137022289RT-SPOTBeekley CorporationJAC2024-08-29
00815137022296RT-SPOTBeekley CorporationJAC2024-08-29
00815137022302RT-SPOTBeekley CorporationJAC2024-08-29
00815137022258RT-SPOTBeekley CorporationJAC2024-08-29
10815137022255RT-SPOTBeekley CorporationJAC2024-08-29
10815137022262RT-SPOTBeekley CorporationJAC2024-08-29
10815137022279RT-SPOTBeekley CorporationJAC2024-08-29
B971RTC120SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12L0SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12S0SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTC121SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12L1SuremarkJessop Precision Products Inc.JAC2024-02-01
B971RTD12S1SuremarkJessop Precision Products Inc.JAC2024-02-01
03613720287971UNiD™ Calibration SphereMEDTRONIC SOFAMOR DANEK, INC.JAC2023-08-20
B971RTC1000SuremarkJessop Precision Products Inc.JAC2023-01-16
B971RTL100SuremarkJessop Precision Products Inc.JAC2023-01-16
00815137022166R-SPOTBeekley CorporationJAC2023-01-09
00815137022173L-SPOTBeekley CorporationJAC2023-01-09
10815137022163R-SPOTBeekley CorporationJAC2023-01-09
10815137022170L-SPOTBeekley CorporationJAC2023-01-09
B201CGVM20Clear Guide VisiMARKER IICLEAR GUIDE MEDICAL, INC.JAC2022-10-04
B201CGVM2NS0Clear Guide VisiMARKER II Non-SterileCLEAR GUIDE MEDICAL, INC.JAC2022-10-04
B201CGVMNS0Clear Guide VisiMARKER Non-SterileCLEAR GUIDE MEDICAL, INC.JAC2022-10-04