GUDID 00613994284587

MESH CMESH-3WK CUSTOM 3WK IMPLANT

MEDTRONIC PS MEDICAL, INC.

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID00613994284587
NIH Device Record Key2705eb05-7485-4c6a-bb8a-65314b2159d4
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberCMESH-3WK
Company DUNS089055867
Company NameMEDTRONIC PS MEDICAL, 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 Batchfalse
Serial Numbertrue
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
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994284587 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


[00613994284587]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-06-24

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

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00763000467401 - NA2024-06-10 CONNECTOR 9041 LUERLOCK TO FIT 1.3MM ID
00763000529338 - Becker External Drainage and Monitoring System2024-05-27 BECKER 27761 STOP BCNDLESS PATLN 24
00763000406073 - Becker2024-04-08 EDMS 46128 BECKER II BLUE PT LN
00763000467340 - NA2024-03-11 KIT 46442 EDM LUMBAR DRN CLS TIP 5PK
00763000406042 - NA2024-03-05 ASSEMBLY 46422 EDM DRAINAGE

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