FDA.reportPublic FDA data

TS1 Base Kit

Primary DI
00860009780408
Brand
TS1 Base Kit
Company
Wheelhouse Medical
Model
TS01-0022
Catalog number
100-TS1
Device description
The Tube Solutions TS1 BASE KIT is a sterile, single-use, disposable device intended for use during tubular retractor surgery.
Published
2023-08-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009780408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009780408008600097804088600097804080860009780408

GMDN Terms#

Term, Definition table
TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7049629429support@tubesolutions.net

Regulatory Flags#

DUNS number
118496839
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850058050157Wheelhouse Medical SpecialsWM01-01412025-10-08
00850058050164Wheelhouse Medical SpecialsWM01-01422025-10-08
00850058050188Wheelhouse Medical SpecialsWM01-01442025-10-08
00850058050225Wheelhouse Medical SpecialsWM01-01482025-10-08
00850058050256Wheelhouse Medical SpecialsWM01-01532025-10-08
00850058050263Wheelhouse Medical SpecialsWM01-01732025-10-08
00850058050287Wheelhouse Medical SpecialsWM01-01572025-10-08
00850058050003Wheelhouse Medical SpecialsWM01-0072-0102024-10-23
00850058050010Wheelhouse Medical SpecialsWM01-0072-0112024-10-23
00850058050027Wheelhouse Medical SpecialsWM01-0072-0122024-10-23
00850058050034Wheelhouse Medical SpecialsWM01-0072-0132024-10-23
00850058050041Wheelhouse Medical SpecialsWM01-0072-0142024-10-23
00850058050058Wheelhouse Medical SpecialsWM01-0072-0152024-10-23
00850058050065Wheelhouse Medical SpecialsWM01-00852024-10-23
00850058050072Wheelhouse Medical SpecialsWM01-00862024-10-23
00850058050089Wheelhouse Medical SpecialsWM01-00782024-10-23
00850058050096Wheelhouse Medical SpecialsWM01-00792024-10-23
00850058050102Wheelhouse Medical SpecialsWM01-01122024-10-23
00850058050119Wheelhouse Medical SpecialsWM01-01172024-10-23
00850058050126Wheelhouse Medical SpecialsWM01-01182024-10-23