FDA.report

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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00819251021340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00819251021340008192510213408192510213400819251021340

GMDN Terms

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

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

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(801)486-6070udi@tjoinc.com

Regulatory Flags

DUNS number
078416717
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
true

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