Zimmer Patient Specific Instruments 00-5970-000-25

GUDID E31400597000025

Materialise NV

Custom-made organ/bone anatomy model/surgical guide kit
Primary Device IDE31400597000025
NIH Device Record Key15013a2a-5761-4ff6-9a90-72f55f8ccb4c
Commercial Distribution Discontinuation2017-07-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameZimmer Patient Specific Instruments
Version Model Number00-5970-000-25
Catalog Number00-5970-000-25
Company DUNS373139427
Company NameMaterialise NV
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE31400597000025 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OOGKnee Arthroplasty Implantation System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[E31400597000025]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-27
Device Publish Date2016-09-24

On-Brand Devices [Zimmer Patient Specific Instruments]

E314005970000480PERSONATM PREF PS Pin Guides (Femur and Tibia) CT
E314005970000450PERSONATM PREF CR Pin Guides (Femur and Tibia) CT
E314005970000420PERSONATM PS Pin Guides (Femur and Tibia) CT
E31400597000039000-5970-000-39
E314005970000360PERSONA PREF PS Pin Guides (Femur and Tibia)
E314005970000330PERSONA PREF CR Pin Guides (Femur and Tibia)
E314005970000290PERSONA PS Pin Guides (Femur and Tibia)
E314005970000250PERSONA CR Pin Guides (Femur and Tibia)
E314005970000190N-K Flex Pin Guides (Femur and Tibia) CT
E31400597000018000-5970-000-18
E314005970000170NexGen® LPS Pin Guides (Femur and Tibia) CT
E314005970000160NexGen® CR-FLEX PIN GUIDES (FEMUR AND TIBIA) CT
E314005970000150NexGen® CR Pin Guides (Femur and Tibia) CT
E314005970000140NexGen® LPS Pin Guides (Femur and Tibia)
E314005970000130NexGen® CR Pin Guides (Femur and Tibia)
E31400597000010000-5970-000-10
E314005970000040Unicompartmental High Flex Knee (Femur and Tibia)
E314005970000030N-K Flex Pin Guides (Femur and Tibia)
E314005970000020NexGen® LPS-FLEX PIN GUIDES (FEMUR AND TIBIA)
E314005970000010NexGen® CR-FLEX PIN GUIDES (FEMUR AND TIBIA)
E31400597000048PERSONATM PREF PS Pin Guides (Femur and Tibia) CT
E31400597000045PERSONATM PREF CR Pin Guides (Femur and Tibia) CT
E31400597000042PERSONATM PS Pin Guides (Femur and Tibia) CT
E3140059700003600-5970-000-36
E3140059700003300-5970-000-33
E3140059700002900-5970-000-29
E3140059700002500-5970-000-25
E31400597000019N-K Flex Pin Guides (Femur and Tibia) CT
E3140059700001800-5970-000-18
E31400597000017NexGen® LPS Pin Guides (Femur and Tibia) CT
E3140059700001600-5970-000-16
E31400597000015NexGen® CR Pin Guides (Femur and Tibia) CT
E31400597000014NexGen® LPS Pin Guides (Femur and Tibia)
E31400597000013NexGen® CR Pin Guides (Femur and Tibia)
E31400597000004Unicompartmental High Flex Knee (Femur and Tibia)
E31400597000003N-K Flex Pin Guides (Femur and Tibia)
E3140059700000200-5970-000-02
E3140059700000100-5970-000-01

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