GUDID 00643169545885

TAPS MODULE NAV2027K LG2NAV TAPS MODULE

MEDTRONIC SOFAMOR DANEK, INC.

Bone tap, reusable
Primary Device ID00643169545885
NIH Device Record Keyb2165cc3-8c89-48d0-b6ac-bdaacc5b1113
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNAV2027K
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169545885 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169545885]

Moist Heat or Steam Sterilization


[00643169545885]

Moist Heat or Steam Sterilization


[00643169545885]

Moist Heat or Steam Sterilization


[00643169545885]

Moist Heat or Steam Sterilization


[00643169545885]

Moist Heat or Steam Sterilization


[00643169545885]

Moist Heat or Steam Sterilization


[00643169545885]

Moist Heat or Steam Sterilization


[00643169545885]

Moist Heat or Steam Sterilization


[00643169545885]

Moist Heat or Steam Sterilization


[00643169545885]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-29

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000764050 - OsteoCool™ 2.0 RF Ablation System2024-11-19 CART OCA01-100 OC 2.0 100W STAND
00763000670542 - n/a2024-11-18 TEMPLATE 3005975 ZEVO 75MM 5 LVL
00763000670559 - n/a2024-11-18 TEMPLATE 3005977 ZEVO 77MM 5 LVL
00763000670566 - n/a2024-11-18 TEMPLATE 3005979 ZEVO 79MM 5 LVL
00763000670573 - n/a2024-11-18 TEMPLATE 3005981 ZEVO 81MM 5 LVL
00763000670580 - n/a2024-11-18 TEMPLATE 3005985 ZEVO 85MM 5 LVL
00763000670597 - n/a2024-11-18 TEMPLATE 3005990 ZEVO 90MM 5 LVL
00763000670603 - n/a2024-11-18 TEMPLATE 3005995 ZEVO 95MM 5 LVL

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.