FDA.reportPublic FDA data

Del Medical, Inc.

Primary DI
00858340006110
Brand
Del Medical, Inc.
Company
Del Medical, Inc.
Model
OTC18S
Device description
An x-ray system component intended to be mounted to the ceiling, to support and facilitate position of the x-ray tube. The OTC18S allows for synchronized tracking and stitching.
Published
2022-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00858340006110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858340006110008583400061108583400061100858340006110

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system tube support, ceiling mountedA component of an x-ray system (diagnostic, therapeutic, radiation therapy simulator) intended to be mounted on the ceiling to mount, support and facilitate positioning of the x-ray tube assembly (not included). It typically consists of a rack with controls. The x-ray tube assembly is attached to the rack and can be moved along the rack and/or tilted. Some designs also support the movement and positioning of an image receptor assembly (e.g., C-arm assembly).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078671236
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858340006202Del Medical, Inc.DM-SARM2022-04-15
00858340006479Del Medical, Inc.KA Reveal Mobi Pro2026-03-05
00858340006523Del Medical, Inc.CM-OTC18T2026-03-05
00858340006530Del Medical, Inc.DMX2026-03-05
00858340006547Del Medical, Inc.VT300 (5187)2026-03-05
00858340006486Del Medical, Inc.CM-OTC18M2024-05-09
00858340006400Del Medical, Inc.FM-OTC18T2024-03-18
00858340006417Del Medical, Inc.FM-OTC18M2024-03-18
00858340006424Del Medical, Inc.FM-FMT18T2024-03-18
00858340006431Del Medical, Inc.FM-FMT18M2024-03-18
00858340006448Del Medical, Inc.MT500-F2024-03-18
00858340006455Del Medical, Inc.MT500-EL2024-03-18
00858340006462Del Medical, Inc.MT500-EB2024-03-18
00858340006387Del Medical, Inc.VS502023-05-16
00858340006073Del Medical, Inc.DM-FWFC2022-04-15
00858340006134Del Medical, Inc.EV800T2022-04-15
00858340006141Del Medical, Inc.VT300T2022-04-15
00858340006158Del Medical, Inc.DM-OTC18S2022-04-15
00858340006165Del Medical, Inc.DM-OTC18T2022-04-15
00858340006172Del Medical, Inc.DM-OTC18M2022-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809832900302SST-4100SSHINYOUNG FOR M CO.,LTD.IYB2026-05-27
00198953054949NAGE Hualun Medical Systems Co., LtdIYB2025-09-30
00195278901880NAGE Hualun Medical Systems Co., LtdIYB2025-06-09
00860008892768Foot and Ankle StandOXOS Medical, Inc.IYB2025-06-02
08800011103088DRGEMDRGEM CorporationIYB2024-10-24
08800011103095DRGEMDRGEM CorporationIYB2024-10-24
08800011103125DRGEMDRGEM CorporationIYB2024-10-24
08800011103132DRGEMDRGEM CorporationIYB2024-10-24
08800011103163DRGEMDRGEM CorporationIYB2024-10-24
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
D678A63410"Provecta HD 16"" Center to Center Wall Mounting Plate"AIR TECHNIQUES, INC.IYB2023-07-11
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