FDA.reportPublic FDA data

ScanX Barrier Envelopes

Primary DI
D678G851121
Brand
ScanX Barrier Envelopes
Company
AIR TECHNIQUES, INC.
Model
G8511-2
Device description
An envelope that provides a barrier against fluid to protect PSP plates used for X-ray images. They also prevent cross contamination between patients.
Published
2023-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEMDental Barriers And Sleeves

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEMDental Barriers And SleevesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D678G851121PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+1 (516) 214-5512mardonio.nicolas@airtechniques.com

Regulatory Flags#

DUNS number
043835081
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D67821701006011VistaScan Ultra View Accessory Kit21701006012026-04-10
D678J1205E0ScanX Duo TouchJ1205EJ1200E2026-03-27
D678J1205R0ScanX Duo TouchJ1205RJ1200R2026-03-27
D678NES44000FlowStar E-standNES44002026-01-05
D678NES44001FlowStar E-standNES44002026-01-05
D678734701Plate Transfer Box734702025-09-05
D678AS50X0AirStarAS50X2025-04-25
D678AS50X1AirStarAS50X2025-04-25
D678AS70X0AirStarAS70X2025-04-25
D67821701005000VistaScan Ultra View21701005002023-04-21
D678J12050ScanX Duo TouchJ1205J12002023-04-21
D678732482K1ScanX Barrier Envelopes73248-2K2023-09-12
D6787324801ScanX Barrier Envelopes73248-02019-08-23
D678A63410"Provecta HD 16"" Center to Center Wall Mounting Plate"A63412023-07-11
D678A63890Provecta HD Single Post Mounting PlateA63892023-07-11
D678A63301Provecta HD 16" Center to Center Wall Mounting PlateA63412023-07-11
D678A63361Provecta HD Single Post Mounting PlateA63892023-07-11
D678AS1200AirStar Clinical Air CompressorAS1202023-06-14
D678AS120C0AirStar Clinical Air CompressorAS120C2023-06-14
D678AS600AirStar Clinical Air CompressorAS602023-06-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456214459JMUJMU DENTAL, INCPEM2026-07-10
00840456214466JMUJMU DENTAL, INCPEM2026-07-10
00840456214473JMUJMU DENTAL, INCPEM2026-07-10
00840456214480JMUJMU DENTAL, INCPEM2026-07-10
00840456214497JMUJMU DENTAL, INCPEM2026-07-10
00840456214503JMUJMU DENTAL, INCPEM2026-07-10
00840456217931JMUJMU DENTAL, INCPEM2026-07-10
00840456217948JMUJMU DENTAL, INCPEM2026-07-10
00840456217955JMUJMU DENTAL, INCPEM2026-07-10
00840456217962JMUJMU DENTAL, INCPEM2026-07-10
00840456217979JMUJMU DENTAL, INCPEM2026-07-10
00840456217986JMUJMU DENTAL, INCPEM2026-07-10
00840456214305JMUJMU DENTAL, INCPEM2026-07-06
00840456214312JMUJMU DENTAL, INCPEM2026-07-06
00840456214329JMUJMU DENTAL, INCPEM2026-07-06
00840456214336JMUJMU DENTAL, INCPEM2026-07-06
00840456214343JMUJMU DENTAL, INCPEM2026-07-06
00840456214350JMUJMU DENTAL, INCPEM2026-07-06
00840456214367JMUJMU DENTAL, INCPEM2026-07-06
00840456214374JMUJMU DENTAL, INCPEM2026-07-06
00840456214381JMUJMU DENTAL, INCPEM2026-07-06
00840456214398JMUJMU DENTAL, INCPEM2026-07-06
00840456214404JMUJMU DENTAL, INCPEM2026-07-06
00840456214411JMUJMU DENTAL, INCPEM2026-07-06
00840456214428JMUJMU DENTAL, INCPEM2026-07-06
00840456214435JMUJMU DENTAL, INCPEM2026-07-06
00840456214442JMUJMU DENTAL, INCPEM2026-07-06
00840456215265JMUJMU DENTAL, INCPEM2026-07-06
00840456215746JMUJMU DENTAL, INCPEM2026-07-06
00840456217184JMUJMU DENTAL, INCPEM2026-07-06