FDA.reportPublic FDA data

Skytron

Primary DI
10841736124861
Brand
Skytron
Company
SKYTRON LLC
Model
4-030-42-9
Catalog number
4-030-42-9
Device description
8 inch Clamp for P.T.E. (2 Pack)
Published
2025-12-03
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
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
10841736124861PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084173612486110841736124861

GMDN Terms#

Term, Definition table
TermDefinition
Medical device service rail clampA clamp designed to fit onto a medical device mounting rail or medical device service rail system to provide a secure method of fixing/mounting (holding) other medical or non-medical devices being used in the vicinity for patient treatment/care. It will typically be used in a hospital ward, a treatment room or an intensive care unit (ICU). It will have a gripping profile that is compatible to the medical rail it is intended to fit and a locking mechanism providing extra safety against inadvertent loosening. To this clamp, other adaptors may be fitted/slotted to provide holders for the devices to be carried, or it may have a dedicated function for which it is solely designed.

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
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841736117085Skytron1-011-01-211-011-01-212022-01-29
10841736117092Skytron1-011-01-221-011-01-222022-01-29
10841736117108Skytron1-011-01-31-011-01-32022-01-29
10841736117115Skytron1-011-01-41-011-01-42022-01-29
10841736117122Skytron1-011-01-51-011-01-52022-01-29
10841736117283Skytron1-011-02-421-011-02-422022-01-29
10841736117313Skytron1-011-02-521-011-02-522022-01-29
10841736117351Skytron1-011-03-51-011-03-52022-01-29
10841736117375Skytron1-011-04-221-011-04-222022-01-29
10841736117382Skytron1-011-04-231-011-04-232022-01-29
10841736117412Skytron1-011-04-431-011-04-432022-01-29
10841736117429Skytron1-011-04-51-011-04-52022-01-29
10841736117443Skytron1-011-05-211-011-05-212022-01-29
10841736117450Skytron1-011-05-221-011-05-222022-01-29
10841736117498Skytron1-011-05-51-011-05-52022-01-29
10841736117603Skytron1-011-06-311-011-06-312022-01-29
10841736117658Skytron1-011-06-3B1-011-06-3B2022-01-29
10841736117726Skytron1-011-06-421-011-06-422022-01-29
10841736117801Skytron1-011-07-211-011-07-212022-01-29
10841736117825Skytron1-011-07-41-011-07-42022-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995221577NASTERIS CORPORATIONFQO2026-06-24
00724995221584NASTERIS CORPORATIONFQO2026-06-24
00724995221591NASTERIS CORPORATIONFQO2026-06-24
00724995221607NASTERIS CORPORATIONFQO2026-06-24
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