Klassic HD Low Profile Acetabular Insert with E-Link Poly

GUDID 00814703013836

Low Profile Acetabular Insert with E-Link Poly, 32mm head, size 60mm

TOTAL JOINT ORTHOPEDICS, INC.

Non-constrained polyethylene acetabular liner
Primary Device ID00814703013836
NIH Device Record Keyf313e2aa-9e8e-4f18-8fcf-a79c52e98d74
Commercial Distribution StatusIn Commercial Distribution
Brand NameKlassic HD Low Profile Acetabular Insert with E-Link Poly
Version Model Number3509.60.032
Company DUNS078416717
Company NameTOTAL JOINT ORTHOPEDICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(801)486-6070
Emailudi@tjoinc.com
Phone+1(801)486-6070
Emailudi@tjoinc.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *The Klassic HD Hip System should be stored in a clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100814703013836 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00814703013836]

Ethylene Oxide


[00814703013836]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2017-11-30

On-Brand Devices [Klassic HD Low Profile Acetabular Insert with E-Link Poly ]

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00814703015182Low Profile Acetabular Insert with E-Link Poly, 28mm head, size 44mm
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00814703015168Low Profile Acetabular Insert with E-Link Poly, 22mm head, size 44mm
00814703013928Low Profile Acetabular Insert with E-Link Poly, 36mm head, size 64mm
00814703013911Low Profile Acetabular Insert with E-Link Poly, 36mm head, size 62mm
00814703013904Low Profile Acetabular Insert with E-Link Poly, 36mm head, size 60mm
00814703013898Low Profile Acetabular Insert with E-Link Poly, 36mm head, size 58mm
00814703013881Low Profile Acetabular Insert with E-Link Poly, 36mm head, size 56mm
00814703013874Low Profile Acetabular Insert with E-Link Poly, 36mm head, size 54mm
00814703013867Low Profile Acetabular Insert with E-Link Poly, 36mm head, size 52mm
00814703013850Low Profile Acetabular Insert with E-Link Poly, 32mm head, size 64mm
00814703013843Low Profile Acetabular Insert with E-Link Poly, 32mm head, size 62mm
00814703013836Low Profile Acetabular Insert with E-Link Poly, 32mm head, size 60mm
00814703013829Low Profile Acetabular Insert with E-Link Poly, 32mm head, size 58mm
00814703013812Low Profile Acetabular Insert with E-Link Poly, 32mm head, size 56mm
00814703013805Low Profile Acetabular Insert with E-Link Poly, 32mm head, size 54mm
00814703013799Low Profile Acetabular Insert with E-Link Poly, 32mm head, size 52mm
00814703013782Low Profile Acetabular Insert with E-Link Poly, 32mm head, size 50mm
00814703013775Low Profile Acetabular Insert with E-Link Poly, 32mm head, size 48mm

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