GUDID 00763000152635

TRAY 7068032 DISTRACTOR DEGEN 5.5/6.0

MEDTRONIC SOFAMOR DANEK, INC.

Instrument tray
Primary Device ID00763000152635
NIH Device Record Key6b8e5d3a-a72e-44f0-9b9d-9c8957c47ea0
Commercial Distribution StatusIn Commercial Distribution
Version Model Number7068032
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
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
GS100763000152635 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KCTSterilization wrap containers, trays, cassettes & other accessories

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


[00763000152635]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-14
Device Publish Date2020-02-06

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

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00763000856472 - Pyramesh® Implant System2025-07-28 MESH 905-412 PYRM 10 X 14 OVOID X 12MM
00763000856489 - Pyramesh® Implant System2025-07-28 MESH 905-415 PYRM 10 X 14 OVOID X 15MM
00763000856502 - Pyramesh® Implant System2025-07-28 MESH 905-508 PYRM 13 X 17 OVOID X 8MM
00763000856519 - Pyramesh® Implant System2025-07-28 MESH 905-509 PYRM 13 X 17 OVOID X 9MM
00763000856526 - Pyramesh® Implant System2025-07-28 MESH 905-511 PYRM 13 X 17 OVOID X 11MM
00763000856533 - Pyramesh® Implant System2025-07-28 MESH 905-512 PYRM 13 X 17 OVOID X 12MM
00763000856557 - Pyramesh® Implant System2025-07-28 MESH 905-520 PYRM 13 X 17 OVOID X 20MM

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