FDA.reportPublic FDA data

Fast Find Grid: Disposable CT Biopsy Grid

Primary DI
10815112020214
Brand
Fast Find Grid: Disposable CT Biopsy Grid
Company
Bracco Diagnostics Inc.
Model
600001
Catalog number
600001
Device description
Fast Find Grid
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KPRSystem, X-Ray, Stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30815112020218PackageGS125In Commercial Distribution
50815112020212PackageGS11500In Commercial Distribution
10815112020214PrimaryGS10
00815112020217Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3081511202021830815112020218
5081511202021250815112020212
1081511202021410815112020214
00815112020217008151120202178151120202170815112020217

GMDN Terms#

Term, Definition table
TermDefinition
Radiological image marker, noninvasive, reusableA non-powered, noninvasive device intended to be placed within the field of view of a radiological device [diagnostic (e.g., x-ray) and/or radiation therapy] to produce an identifying mark [typically for an anatomical location (e.g., mole, nipple, lesion), orientation (e.g., right or left limb), or patient identification] on films or digital images; it is not intended to be used during surgery. It is typically in the form of a small sticker, clip, or plate, and is positioned on or next to the patient, or on the film cassette or holder; it is not intended to be placed on teeth. It is made from materials compatible with the imaging system. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
609-514-2200xx@xx.xx

Regulatory Flags#

DUNS number
849234661
Device count
25
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10815112021167Rounded Flexi Tip Adult Enema Tip9013019013012023-05-25
10815112021181Miller Enema Air Tip with Non-Latex Retention Cuff9012019012012023-05-25
10815112021198Miller Enema Air Tip with Retention Cuff9012029012022023-05-25
30815112021703Two Tank Shuttle Valve System7106027106022025-06-30
30815112021710DIN 477 High Pressure Hose for CO23905133905132025-06-30
30815112021291High Pressure Hose and Yoke7106037106032023-08-31
10815112021174Enema Kit: Empty Enema Bag Delivery System9003029003022023-05-25
1081511202120418 French Pediatric Flexi Tip9013089013082023-05-25
30815112020805High Pressure DISS Hose For CO27106047106042016-09-19
30815112020782Two Tank Shuttle Valve System7106027106022016-09-19
10815112020535E-Z-GEL UltraSound Gel6010016010012016-09-23
10815112020542E-Z-SCAN Low Viscosity UltraSound Gel6010026010022016-09-23
10815112020559E-Z-SCAN Low Viscosity UltraSound Gel6010036010032016-09-23
10815112020566E-Z-GEL UltraSound Gel6010046010042016-09-23
10815112021402E-Z-GEL UltraSound Gel6010016010012025-05-16
10815112021419E-Z-SCAN Low Viscosity UltraSound Gel6010026010022025-05-16
10815112021426E-Z-SCAN Low Viscosity UltraSound Gel6010036010032025-05-16
10815112021433E-Z-GEL UltraSound Gel6010046010042025-05-16
10815112020856"""Y"" Connector with Tubing"9004029004022016-09-19
10815112021693Cysto-Aid: Urine Collection Device9010049010042026-01-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08908021109004PRORAD 3NCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08908021109011PRORAD 2FCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08809365280001SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
00198953056103DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
04056869297309MOBILETT ImpactSiemens Healthcare GmbHKPR2025-11-20
00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
00195278840226DiscoveryGE Hualun Medical Systems Co., LtdKPR2024-07-04
04540217071319RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
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04540217071357RADspeed ProSHIMADZU CORPORATIONKPR2024-04-01
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00195278526892DefiniumGE Hualun Medical Systems Co., LtdKPR2023-09-18
00884838110588Precision CRFPhilips Medical Systems DMC GmbHKPR2023-02-14
B216DRH700AC1X-CEL X-RAY CORPORATIONARQUILLA, INC.KPR2022-12-20
00884838103221ProxiDiagnost N90Philips Medical Systems DMC GmbHKPR2022-01-17
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
00195278070265DefiniumGE Hualun Medical Systems Co., LtdKPR2020-11-24
00810035220386Radmedix AcuityFDRRADMEDIX, LLCKPR2020-09-18
00810035220393Radmedix AcuityFDR+RADMEDIX, LLCKPR2020-09-18
00810035220409Radmedix AcuityCDRRADMEDIX, LLCKPR2020-09-18
00810035220416Radmedix AcuitySDRRADMEDIX, LLCKPR2020-09-18
00810035220423Radmedix AcuitySDR+RADMEDIX, LLCKPR2020-09-18
00810030350071uDRUIH TECHNOLOGIES LLCKPR2020-05-26
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08800011121235FDR ClinicaDRGEM CorporationKPR2019-11-20