FDA.reportPublic FDA data

Klassic BiPolar Sizing Plate

Primary DI
00819251021340
Brand
Klassic BiPolar Sizing Plate
Company
TOTAL JOINT ORTHOPEDICS, INC.
Model
1320.00.000
Device description
BiPolar Sizing Plate
Published
2019-10-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00819251021340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00819251021340008192510213408192510213400819251021340

GMDN Terms#

Term, Definition table
TermDefinition
Atrial septal defect sizing plateA sterile, plastic plate containing a series of holes of varying diameters intended to be used to measure the diameter of an inflated sizing balloon of a cardiac catheter to assist in determining the size of an atrial septal defect. It is typically used during transcatheter closure of the defect by positioning the balloon within the defect, recording the amount of fluid required to fill the balloon to the size of the defect, then refilling the balloon outside the body and passing it through the various holes of the plate to determine the diameter. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, Specify00The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)486-6070udi@tjoinc.com

Regulatory Flags#

DUNS number
078416717
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810094692803Klassic Blade Femoral Broach, Line-To-Line, size 0SRI-10054.002026-07-27
00810094692810Klassic Blade Femoral Broach, Line-To-Line, size 1SRI-10054.012026-07-27
00810094692827Klassic Blade Femoral Broach, Line-To-Line, size 2SRI-10054.022026-07-27
00810094692834Klassic Blade Femoral Broach, Line-To-Line, size 3SRI-10054.032026-07-27
00810094692841Klassic Blade Femoral Broach, Line-To-Line, size 4SRI-10054.042026-07-27
00810094692858Klassic Blade Femoral Broach, Line-To-Line, size 5SRI-10054.052026-07-27
00810094692865Klassic Blade Femoral Broach, Line-To-Line, size 6SRI-10054.062026-07-27
00810094692872Klassic Blade Femoral Broach, Line-To-Line, size 7SRI-10054.072026-07-27
00810094692889Klassic Blade Femoral Broach, Line-To-Line, size 8SRI-10054.082026-07-27
00810094692896Klassic Blade Femoral Broach, Line-To-Line, size 9SRI-10054.092026-07-27
00810094692902Klassic Blade Femoral Broach, Line-To-Line, size 10SRI-10054.102026-07-27
00810094692919Klassic Blade Femoral Broach, Line-To-Line, size 11SRI-10054.112026-07-27
00810094692926Klassic Blade Femoral Broach, Line-To-Line, size 12SRI-10054.122026-07-27
00810094692698Modular Frog Eyes2263.00.0002026-06-09
00810094692704Distal Femoral Cut Block Connector2174.00.0002026-06-09
00810094692797Tibial Reamer, Square Tip, Klassic ONE 25/50mm2264.00.0002026-06-09
00810094692933Magnet Spacer, 5mm2027.00.0002026-06-09
00810094692940AP Sizer with Short LegsSRI-100502026-05-15
00810094692728CR Femoral Trial, Grit BlastedSRI-10051.012026-02-05
00810094692735CR Femoral Trial, Grit BlastedSRI-10051.022026-02-05

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00840606185929PrimusSPINAL ELEMENTS, INC.LXH2026-09-24
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