FDA.reportPublic FDA data

PINHOLE Collimator

Primary DI
00850816007140
Brand
PINHOLE Collimator
Company
DIGIRAD CORPORATION
Model
PINHOLE
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYXCamera, Scintillation (Gamma)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYXCamera, Scintillation (Gamma)Radiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850816007140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850816007140008508160071408508160071400850816007140

GMDN Terms#

Term, Definition table
TermDefinition
Single-hole nuclear medicine system collimator, pinholeA conical shaped housing of lead or equivalent material with a single small opening of a fixed diameter at the tapered end of the cone. It projects an inverted image of photon distribution onto the system's crystal detector ensuring that only gamma ray activity directly in front of the collimator channel reaches the scintillation crystal of the imaging or detector system. The shape of its base is intended to conform to the crystal shape of the nuclear medicine imaging system. Typically interchangeable, it is designed with attachment mechanisms that enable it to be safely transported, removed from, or attached to the detector head of the system.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8587261600callcenter@digirad.com

Regulatory Flags#

DUNS number
148548738
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850816007195Breast Imaging Accessory BIA2016-09-12
00850816007027LEHR Collimator LEHR2016-09-12
00850816007034Cardius 2XPOD2016-09-09
00850816007041Cardius 2Mobile XPOD2016-09-09
00850816007058Cardius 2XPOD International2016-09-09
00850816007065Cardius 2Mobile XPOL2016-09-09
00850816007072Cardius 3XPOD2016-09-09
00850816007089Cardius 3Mobile XPOD2016-09-09
00850816007096Cardius 1Mobile2016-09-09
00850816007102Cardius X-ActDomestic2016-09-09
00850816007119Cardius X-ActInternational2016-09-09
00850816007126LEAP CollimatorLEAP2016-09-12
00850816007133MEAP CollimatorMEAP2016-09-12
00850816007157Diverging CollimatorDiverging2016-09-12
00850816007164Mamo CollimatorMamo2016-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859873006219Hermia OLINDAHermes Medical Solutions ABIYX2026-03-10
00810149098215R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-12-15
00810149098116R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-10-15
B843UNISYN7510UniSynConvergent Imaging Solutions IncorporatedIYX2025-08-20
00810149098000R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-07-14
00810149097966R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-05-22
00810149097928R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-03-04
00810149097799R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097836R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097843R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-02-13
00810149097737R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-29
00810149097713R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-14
00810149097706R&D Batteries, Inc.R & D Batteries, Inc.IYX2025-01-07
00810149097683R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-12-13
00810149097690R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-12-13
00810149097638R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-11-05
00810149097621R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-11-04
00810149097607R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-10-22
00810149097584R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-10-17
00810149097546R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-09-12
00810149097522R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-09-06
00810149097409R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-08-09
00810149097287R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-06-18
00810149097270R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-04-15
00810149097263R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-03-05
00810149090073R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090141R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090158R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090196R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01
00810149090202R&D Batteries, Inc.R & D Batteries, Inc.IYX2024-01-01