GUDID 00643169693838

DRIVER NAV2024K SOLERA 4.75 STANDARD MAS

MEDTRONIC SOFAMOR DANEK, INC.

Surgical screwdriver, reusable Surgical screwdriver, reusable
Primary Device ID00643169693838
NIH Device Record Keyb4ccf1d0-3f6d-4d9e-9447-90b76818e9b7
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberNAV2024K
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

Device Dimensions

Outer Diameter4.75 Millimeter
Outer Diameter4.75 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169693838 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169693838]

Moist Heat or Steam Sterilization


[00643169693838]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-10-05
Device Publish Date2016-08-29

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000085353 - ARTiC-L™ Spinal System2024-06-28 TRIAL 5251100 L 25 HT 11 DEG 0 FIXED
00763000700485 - MSB Reusable Instruments2024-06-28 OSTEOTOME EX0222042 STRAIGHT 12.7MM
00613994104441 - MSB Reusable Instruments2024-06-24 INSTRUMENT X0805222 RIGHT HALF TUBE90MM
00763000359720 - CD HORIZON® Spinal System2024-06-24 MODULE 7050534R CDHL HOOK STAGING MOD
00763000917975 - MSB Reusable Instruments2024-06-24 RETRACTOR EX0823013 HAND HELD TISSUE
00763000920159 - MSB Reusable Instruments2024-06-24 SPREADER EX0323002 LAMINA ANGLED
00885074417615 - CAPSTONE® Spinal System2024-06-24 INSERTER X0105157 THREADED
00885074309620 - n/a2024-06-03 INSTRUMENT 6971105 SHIM DISTRACTOR 5MM

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