FDA.reportPublic FDA data

"Provecta HD 16"" Center to Center Wall Mounting Plate"

Primary DI
D678A63410
Brand
"Provecta HD 16"" Center to Center Wall Mounting Plate"
Company
AIR TECHNIQUES, INC.
Model
A6341
Device description
"The Provecta HD 16"" Center to Center Wall Mounting Plate is used to secure the Provecta HD X-ray unit onto a facility wall via two wooden 2""x4"" wall studs located 16 inches on center apart. "
Published
2023-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYBTube Mount, X-Ray, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYBTube Mount, X-Ray, DiagnosticRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D678A63301PackageHIBCC1In Commercial Distribution
D678A63410PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made medical device mountA structure intended to be permanently-fixed to the ceiling and/or wall to support/stow a medical device(s) [e.g., light, monitor, surgical instruments] or stow/provide medical supplies. It is designed with specific characteristics as requested by a healthcare professional to meet the requirements of a specific facility. It may incorporate a pole, rack, shelves, electricity supply sockets, gas outlets, and/or enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device(s) to be mounted is not included.

Contacts#

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

Regulatory Flags#

DUNS number
043835081
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
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
D678AS60C0AirStar Clinical Air CompressorAS60C2023-06-14

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Primary DI, Brand, Company table
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08800011103170DRGEMDRGEM CorporationIYB2024-10-24
08809832900258SD-3100SHINYOUNG FOR M CO.,LTD.IYB2024-04-04
B884SVMS4000VMS 400Pausch, L.L.C.IYB2024-02-16
08809832900074LSS-2000SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900098SST-3100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900104SST-3001SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900227SS-2100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
08809832900234SS-2100SHINYOUNG FOR M CO.,LTD.IYB2023-11-20
05999116100269F100 TS99N TUBE MOUNTCONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő RészvénytársaságIYB2023-08-15
D678A63890Provecta HD Single Post Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
D678A63301Provecta HD 16" Center to Center Wall Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
D678A63361Provecta HD Single Post Mounting PlateAIR TECHNIQUES, INC.IYB2023-07-11
B884S10000110R0Paxis 100 AutoPausch, L.L.C.IYB2023-05-12
S10000110R0Paxis 100 AutoPausch, L.L.C.IYB2023-05-03
B884S10000110L0Paxis 100 AutoPausch, L.L.C.IYB2023-05-03
B884S04201000L0CirrusPausch, L.L.C.IYB2022-12-23
B884S04201000R0CirrusPausch, L.L.C.IYB2022-12-23
B884S100002000Paxis 200Pausch, L.L.C.IYB2022-12-23
B884S10000100L0Paxis 100Pausch, L.L.C.IYB2022-12-06
B884S10000100R0Paxis 100Pausch, L.L.C.IYB2022-12-06
00195278569745NAGE Hualun Medical Systems Co., LtdIYB2022-07-21