FDA.reportPublic FDA data

LEHR Collimator

Primary DI
00850816007027
Brand
LEHR Collimator
Company
DIGIRAD CORPORATION
Model
LEHR
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
00850816007027PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850816007027008508160070278508160070270850816007027

GMDN Terms#

Term, Definition table
TermDefinition
Multi-hole nuclear medicine system collimator, low-energyA device designed specifically for use in diagnostic nuclear medicine imaging applications operating with an energy range of less than 500 kilo-electronvolt (keV). It consists of an array of small openings drilled or cast into a flat sheet or plate of lead or lead-equivalent materials. Its size and shape is intended to conform to the crystal shape of a nuclear medicine imaging system to ensure that only gamma ray activity directly in front of the individual collimator channels reaches the scintillation. It has attachment mechanisms that enable it to be safely transported, removed from, and 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
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
00850816007140PINHOLE CollimatorPINHOLE 2016-09-12
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