GUDID 00763000140274

HOLDER 9564008 ENDOSCOPE 18

MEDTRONIC SOFAMOR DANEK, INC.

Surgical retraction system, reusable
Primary Device ID00763000140274
NIH Device Record Keyeb1b53aa-d02d-4031-aa4d-2a02731e7fb6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number9564008
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000140274 [Primary]

FDA Product Code

GADRETRACTOR

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


[00763000140274]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-04
Device Publish Date2021-09-24

Devices Manufactured by MEDTRONIC SOFAMOR DANEK, INC.

00763000883492 - IB3D™ PL Spinal System2025-04-08 TRAY A24100100 IB3D PL TRAY
00763000964634 - CD Horizon™ ModuLeX™ Spinal System2025-04-08 SHANK 55901504015 ST MDX OSTEOGR 4.0X15
00763000964641 - CD Horizon™ ModuLeX™ Spinal System2025-04-08 SHANK 55901504020 ST MDX OSTEOGR 4.0X20
00763000964658 - CD Horizon™ ModuLeX™ Spinal System2025-04-08 SHANK 55901504022 ST MDX OSTEOG 4.0X22.5
00763000964665 - CD Horizon™ ModuLeX™ Spinal System2025-04-08 SHANK 55901504025 ST MDX OSTEOGR 4.0X25
00763000964672 - CD Horizon™ ModuLeX™ Spinal System2025-04-08 SHANK 55901504027 ST MDX OSTEOG 4.0X27.5
00763000964689 - CD Horizon™ ModuLeX™ Spinal System2025-04-08 SHANK 55901504030 ST MDX OSTEOGR 4.0X30
00763000964696 - CD Horizon™ ModuLeX™ Spinal System2025-04-08 SHANK 55901504032 ST MDX OSTEOG 4.0X32.5

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.