FDA.reportPublic FDA data

GuideLines

Primary DI
00815137021510
Brand
GuideLines
Company
Beekley Corporation
Model
117S
Device description
"CT Grid for Localizing Needle Entry Sites, 4x5"" biopsy grid"
Published
2019-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IXJGrid, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXJGrid, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815137021510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815137021510008151370215108151370215100815137021510

GMDN Terms#

Term, Definition table
TermDefinition
Radiographic image marker, manualAn object that is manually configured and physically placed within the field of view of a medical or dental diagnostic imaging system [e.g., x-ray, magnetic resonance imaging (MRI), or nuclear medicine] and leaves identifying marks on either films or digital images created using various diagnostic imaging modalities. It can be positioned either on a patient's body, or next to a patient, or be affixed to the film cassette or holder. It is made from materials compatible with the imaging system with which it is intended to be used. Typically used to imprint information on the images related to image acquisition parameters and/or patient identification, and to record anatomical information.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
001157841
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815137021077ColdSPOT5002019-07-22
00815137021084ColdSPOT5022019-07-22
00815137021060ColdSPOT5052019-07-22
00815137021978ColdSPOT500S2019-07-22
00815137021985ColdSPOT502S2019-07-22
00815137021992ColdSPOT505S2019-07-22
00815137022043TenderTouch4182020-07-31
00815137022050TenderTouch418S2020-07-31
00815137020056PointGuards1152019-07-22
00815137020254PointGuards3152019-07-22
00815137020261PointGuards3162019-07-22
00815137020278PointGuards3182019-07-22
00815137021398PointGuards115S2019-07-22
00815137021541PointGuards215S2019-07-22
00815137021619PointGuards315S2019-07-22
00815137021626PointGuards316S2019-07-22
00815137021633PointGuards318S2019-07-22
00815137022326InkRight5115112024-10-23
00815137022333InkRight510S510S2024-10-23
00815137022340InkRight511S511S2024-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589744213199MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-12-19
04589744212628GRID FacileMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
04589744212666MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
04589744213069MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
04589744213076MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
00884838125322Grid Landscape for SkyPlate E Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125339Grid Landscape for SkyPlate large Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125346Grid Portrait for SkyPlate E Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125353Grid Portrait for SkyPlate largePhilips Medical Systems DMC GmbHIXJ2025-06-19
00884838125360Grid Portrait for SkyPlate small Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125384Grid Portrait Fiber PaxScan4336WPhilips Medical Systems DMC GmbHIXJ2025-06-19
00884838125391Grid Landscape Fiber PaxScan4336WPhilips Medical Systems DMC GmbHIXJ2025-06-19
00884838125421X-Ray Grid 40/12/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125438X-Ray Grid 40/12/180 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125445X-Ray Grid 40/12/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125452X-Ray Grid 60/10/180 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125469X-Ray Grid 60/10/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125476X-Ray Grid 60/10/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125483X-Ray Grid 44/8/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125490X-Ray Grid 40/8/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125506X-Ray Grid 40/8/180Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125513X-Ray Grid 40/8/110Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125520X-Ray Grid 36/8/180 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125537X-Ray Grid 36/8/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125544X-Ray Grid 36/8/110Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125551X-Ray Grid 36/12/140 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125568X-Ray Grid 36/12/180Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125575X-Ray Grid 36/12/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125582X-Ray Grid 36/12/100 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125599X-Ray Grid 44/8/140 Philips Medical Systems DMC GmbHIXJ2025-06-19