FDA.reportPublic FDA data

Skytron

Primary DI
10841736122430
Brand
Skytron
Company
SKYTRON LLC
Model
3-041-03
Catalog number
3-041-03
Device description
G-Series Lower Back Section
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
10841736122430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173612243010841736122430

GMDN Terms#

Term, Definition table
TermDefinition
Operating/examination/treatment table headrest, reusableA device designed to be attached to an operating/examination/treatment table to support the head, and sometimes shoulders, of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations conducted on such tables. This is a general-purpose headrest typically made of metal and synthetic materials that incorporate a cushion or pad that provides a softer surface for the patient's head to rest upon. It is available in various shapes and sizes and will typically include mechanical mechanisms to enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.

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
Serial number
true
Manufacturing date on label
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