AS ENDURO NB078Z

GUDID 04046963177935

AS ENDURO TIBIA HEMI-WEDGE T3 16MM RL/LM

Aesculap AG

Knee arthroplasty wedge

Primary Device ID	04046963177935
NIH Device Record Key	7c272d98-5675-4c7b-9d7c-0b36215f895c
Commercial Distribution Status	In Commercial Distribution
Brand Name	AS ENDURO
Version Model Number	NB078Z
Catalog Number	NB078Z
Company DUNS	315018218
Company Name	Aesculap AG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com
Phone	+1(888)229-3002
Email	setworld_orders@aesculap.com

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04046963177935 [Primary]

FDA Product Code

KRO	PROSTHESIS, KNEE, FEMOROTIBIAL, CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2019-04-02
Device Publish Date	2015-09-24

On-Brand Devices [AS ENDURO]

04046963177935	AS ENDURO TIBIA HEMI-WEDGE T3 16MM RL/LM
04046963177928	AS ENDURO TIBIA HEMI-WEDGE T2 16MM RL/LM
04046963177911	AS ENDURO TIBIA HEMI-WEDGE T3 12MM RL/LM
04046963177904	AS ENDURO TIBIA HEMI-WEDGE T2 12MM RL/LM
04046963177881	AS ENDURO TIBIA HEMI-WEDGE T3 8MM RL/LM
04046963177867	AS ENDURO TIBIA HEMI-WEDGE T2 8MM RL/LM
04046963177850	AS ENDURO TIBIA HEMI-WEDGE T3 4MM RL/LM
04046963177836	AS ENDURO TIBIA HEMI-WEDGE T2 4MM RL/LM
04046963177812	AS ENDURO TIBIA HEMI-WEDGE T3 16MM RM/LL
04046963177805	AS ENDURO TIBIA HEMI-WEDGE T2 16MM RM/LL
04046963177799	AS ENDURO TIBIA HEMI-WEDGE T3 12MM RM/LL
04046963177775	AS ENDURO TIBIA HEMI-WEDGE T2 12MM RM/LL
04046963177751	AS ENDURO TIBIA HEMI-WEDGE T3 8MM RM/LL
04046963177744	AS ENDURO TIBIA HEMI-WEDGE T2 8MM RM/LL
04046963177737	AS ENDURO TIBIA HEMI-WEDGE T3 4MM RM/LL
04046963177713	AS ENDURO TIBIA HEMI-WEDGE T2 4MM RM/LL
04046963177706	AS ENDURO TIBIA HEMI-WEDGE T1 16MM RL/LM
04046963177683	AS ENDURO TIBIA HEMI-WEDGE T1 12MM RL/LM
04046963177676	AS ENDURO TIBIA HEMI-WEDGE T1 8MM RL/LM
04046963177621	AS ENDURO TIBIA HEMI-WEDGE T1 4MM RL/LM
04046963177591	AS ENDURO TIBIA HEMI-WEDGE T1 16MM RM/LL
04046963177584	AS ENDURO TIBIA HEMI-WEDGE T1 12MM RM/LL
04046963177577	AS ENDURO TIBIA HEMI-WEDGE T1 8MM RM/LL
04046963177560	AS ENDURO TIBIA HEMI-WEDGE T1 4MM RM/LL
04046963937805	AS ENDURO MENISCAL COMPONENT F3 16MM
04046963937775	AS ENDURO MENISCAL COMPONENT F3 10MM
04046963937713	AS ENDURO MENISCAL COMPONENT F2 14MM
04046963937706	AS ENDURO MENISCAL COMPONENT F2 12MM
04046963937645	AS ENDURO MENISCAL COMPONENT F1 14MM
04046963937591	AS ENDURO FEMUR SPACER DISTAL F3 4MM
04046963937577	AS ENDURO FEMUR SPACER DISTAL F2 8MM
04046963937478	AS ENDURO FEM.SPACER POST/DIST F2 8X12MM
04046963937362	AS ENDURO FEM.SPACER POST/DIST F1 4X12MM
04046963937317	AS ENDURO FEM.SPACER POST/DIST F2 8X4MM
04046963937294	AS ENDURO FEM.SPACER POST/DIST F1 8X8MM
04046963937263	AS ENDURO FEM.SPACER POST/DIST F1 4X4MM
04046963177553	AS ENDURO FEMORAL COMPONENT CEMENTED F3R
04046963177508	AS ENDURO FEMORAL COMPONENT CEMENTED F3L
04046963177454	AS ENDURO TIBIAL COMP.OFFSET CEMENTED T1