StandTall

Primary DI
10853714008025
Brand
StandTall
Company
RADUX DEVICES, LLC
Model
ST0015L
Catalog number
ST0015L
Device description
Sheath Extender and Securement Clasp, 15cm
Published
2019-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853714008025PackageGS15In Commercial Distribution
00853714008028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085371400802510853714008025
00853714008028008537140080288537140080280853714008028

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access procedure kitA collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter2.7Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-935-3137hillari.jacobs@raduxdevices.com

Regulatory Flags#

DUNS number
079668796
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853714008011StandTallST0025LST0025L2019-08-16
00853714008028StandTallST0015LST0015L2019-08-16
00853714008004StandTallST0010LST0010L2019-08-16
00853714008103Steradian ShieldSS0300SS03002025-07-16
00853714008080Steradian ShieldSS0200SS02002023-02-02
00853714008042LASSLP1002LP10022024-01-31
00853714008059LASSLP1001LP10012024-01-31
00853714008066LASSLP1003LP10032024-01-31
00853714008073LASSLP1004LP10042024-01-31
00853714008035Steradian ShieldSS0100SS01002019-09-25
10853714008087Steradian ShieldSS0200SS02002023-02-02
10853714008032Steradian ShieldSS0100SS01002019-09-25
10853714008018StandTallST0025LST0025L2019-08-16

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Primary DI, Brand, Company table
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