GPS

Primary DI
00817800020646
Brand
GPS
Company
GROUP PRACTICE SOLUTIONS INC.
Model
45-8800
Device description
BARRIER ENVELOPES SIZE 1
Published
2016-12-05
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
IXCIlluminator, Radiographic-Film

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXCIlluminator, Radiographic-FilmRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817800020646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817800020646008178000206468178000206460817800020646

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging cassette/storage phosphor screen, dentalA combination device for dental applications that consists of a cassette (barrier envelope) used to hold and shield an attached phosphor storage screen [mounted on a phosphor storage plate (PSP)] from exposure to room light during transport and insertion into a diagnostic dental x-ray system, and a computed radiography scanner. The photostimulatable phosphor storage screen is exposed to radiation by the dental x-ray system to record a patient radiation pattern. The cassette is then loaded into a laser scanner capable of reading the latent image formed on the storage phosphor screen to produce a digital image. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968188644
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817800020752GPS21-010021-01002017-05-30
90817800020267GPS45-15102016-12-05
90817800020281GPS45-15112016-12-05
90817800020304GPS45-15302016-12-05
90817800020328GPS45-15312016-12-05
90817800020342GPS45-15502016-12-05
90817800020366GPS45-15512016-12-05
00817800020493GPS45-15012016-12-05
00817800020509GPS45-15022016-12-05
00817800020516GPS45-15032016-12-05
00817800020523GPS45-15402016-12-05
90817800020014GPS45-20012016-12-05
90817800020021GPS45-20022016-12-05
90817800020038GPS45-20032016-12-05
90817800020045GPS45-01502016-12-05
90817800020069GPS45-02502016-12-05
90817800020083GPS45-03502016-12-05
90817800020106GPS45-05502016-12-05
90817800020120GPS45-15002016-12-05
90817800020144GPS45-21502016-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00696588005836Porta-View™Innovative Medical Products, IncIXC2019-11-25
00696588005843Porta-View™Innovative Medical Products, IncIXC2019-11-25
00696588005850Porta-View™Innovative Medical Products, IncIXC2019-11-25
00696588000985Porta-View™Innovative Medical Products, IncIXC2019-09-11
00816577022341DefendYOUNG MYDENT, LLCIXC2017-03-23
00816577022358DefendYOUNG MYDENT, LLCIXC2017-03-23
00816577022365DefendYOUNG MYDENT, LLCIXC2017-03-23
00817800020479GPSGROUP PRACTICE SOLUTIONS INC.IXC2016-12-05
00817800020653GPSGROUP PRACTICE SOLUTIONS INC.IXC2016-12-05
00816577022082DefendYOUNG MYDENT, LLCIXC2016-10-28
00816577022099DefendYOUNG MYDENT, LLCIXC2016-10-28
00816577022075DefendYOUNG MYDENT, LLCIXC2016-10-26