FDA.reportPublic FDA data

Skytron

Primary DI
10841736122836
Brand
Skytron
Company
SKYTRON LLC
Model
5-010-19-1
Catalog number
5-010-19-1
Device description
3/8 Inch X-RAY TOP SET 1700 WITHOUT STAND OFFS OR VELCRO
Published
2022-01-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FQOTABLE, OPERATING-ROOM, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQOTable, Operating-Room, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841736122836PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173612283610841736122836

GMDN Terms#

Term, Definition table
TermDefinition
Fluoroscopy/angiography table topA component of a modular operating table designed as a detachable table top constructed for use during surgical procedures requiring fluoroscopic guidance, such as cardiovascular surgery and other interventional radiology procedures (e.g., biopsy). This table top is typically a one-piece, and completely flat construction with an x-ray translucent section(s) providing x-rays free of artefacts. It is not dedicated to breast biopsy, and not designed to position a patient during other specialist surgeries (i.e., it is not a specialist operating table top with x-ray transparent features).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800) 759-8766info@skytron.us

Regulatory Flags#

DUNS number
078375583
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736125271Skytron4-040-224-040-222026-05-01
10841736125257Sterling Washers291853329185332026-04-26
10841736124441SkytronSOFPADII1-021-03-22026-04-14
10841736124458SkytronSOFPADII1-021-03-32026-04-14
10841736124465SkytronSOFPADII1-021-03-42026-04-14
10841736124472SkytronSOFPADII1-021-06-22026-04-14
10841736124489SkytronSOFPADII1-021-06-32026-04-14
10841736124496SkytronSOFPADII1-021-06-42026-04-14
10841736124502SkytronSOFPADII1-021-07-22026-04-14
10841736124519SkytronSOFPADII1-021-07-32026-04-14
10841736124526SkytronSOFPADII1-021-07-42026-04-14
10841736124533SkytronSOFPADII1-021-08-22026-04-14
10841736124540SkytronSOFPADII1-021-08-32026-04-14
10841736124557SkytronSOFPADII1-021-08-42026-04-14
10841736124564SkytronSOFPADII1-021-11-22026-04-14
10841736124571SkytronSOFPADII1-021-11-32026-04-14
10841736124588SkytronSOFPADII1-021-11-42026-04-14
10841736124595SkytronSOFPADII1-021-12-22026-04-14
10841736124601SkytronSOFPADII1-021-12-32026-04-14
10841736124618SkytronSOFPADII1-021-12-42026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995232016NASTERIS CORPORATIONFQO2026-05-26
00724995232023NASTERIS CORPORATIONFQO2026-05-26
00724995232054NASTERIS CORPORATIONFQO2026-05-26
00724995232061NASTERIS CORPORATIONFQO2026-05-26
00724995232078NASTERIS CORPORATIONFQO2026-05-26
04260217220899WB FA24Amtrion GmbHFQO2026-04-08
00724995362317HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362324HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362331HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362348HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362355HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362362HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362379HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362386HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362393HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362409HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362416HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362423HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362430HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362447HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
00724995362454HarmonyAIRSTERIS CORPORATIONFQO2026-04-01
10841736124410Skytron 200 x 400 VESA Adapter PlateSKYTRON LLCFQO2026-03-19
04061591001032MultibarOndal Medical Systems GmbHFQO2026-02-02
00190376678665ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678672ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678689ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678740ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678757ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678764ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23
00190376678771ATEC A.R.M.ALPHATEC SPINE, INC.FQO2025-12-23