FDA.reportPublic FDA data

Skytron

Primary DI
10841736100803
Brand
Skytron
Company
SKYTRON LLC
Model
SkyVac
Catalog number
SES6
Device description
Adapter tubing 7/8x3/8x2
Published
2016-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAZTUBING, NONINVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841736100803PrimaryGS10
00084173610082Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084173610080310841736100803
00084173610082000841736100820841736100820084173610082

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter0.375Inch
Outer Diameter0.875Inch
Outer Diameter2Inch

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)759-8767info@skytron.us

Regulatory Flags#

DUNS number
078375583
Device count
12
Premarket exempt
true
No natural rubber latex
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

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Primary DI, Brand, Company table
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00840113242818BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-04
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