Del La Cruz

GUDID 00681490035347

PROSTHESIS 1156278 DE LA CRUZ .6X3.75

MEDTRONIC XOMED, INC.

Ossicular prosthesis, total Ossicular prosthesis, total
Primary Device ID00681490035347
NIH Device Record Key41bd60a8-5d10-49f2-9109-e54f4af9926b
Commercial Distribution Discontinuation2018-06-01
Commercial Distribution StatusNot in Commercial Distribution
Brand NameDel La Cruz
Version Model Number1156278
Company DUNS835465063
Company NameMEDTRONIC XOMED, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100681490035347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ETBPROSTHESIS, PARTIAL OSSICULAR REPLACEMENT

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2015-06-23

On-Brand Devices [Del La Cruz]

00681490035392PROSTHESIS 1156283 DE LA CRUZ .6X5.0
00681490035385PROSTHESIS 1156282 DE LA CRUZ .6X4.75
00681490035378PROSTHESIS 1156281 DE LA CRUZ .6X4.50
00681490035361PROSTHESIS 1156280 DE LA CRUZ .6X4.25
00681490035354PROSTHESIS 1156279 DE LA CRUZ .6X4.0
00681490035347PROSTHESIS 1156278 DE LA CRUZ .6X3.75

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