GUDID 20763000842530

COVER 6177 PACK STERILE SLEEVE GLOBAL

MEDTRONIC, INC.

Medical equipment drape, single-use
Primary Device ID20763000842530
NIH Device Record Key552060f1-72aa-44ce-9737-34262722dbd6
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6177
Company DUNS006261481
Company NameMEDTRONIC, 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 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
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 Dimensions

Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter
Length305 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000842536 [Primary]
GS120763000842530 [Package]
Contains: 00763000842536
Package: PK [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KRGProgrammer, pacemaker

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-20
Device Publish Date2023-11-11

Devices Manufactured by MEDTRONIC, INC.

00763000643416 - OmniaSecure™ MRI SureScan™2025-12-29 LEAD 3930M69 US MKT 69 CM DF4 MR EN
00763000643430 - OmniaSecure™ MRI SureScan™2025-12-29 LEAD 3930M74 US MKT 74 CM DF4 MR EN
00763000643454 - OmniaSecure™ MRI SureScan™2025-12-29 LEAD 3930M79 US MKT 79 CM DF4 MR EN
00763000643478 - OmniaSecure™ MRI SureScan™2025-12-29 LEAD 3930M84 US MKT 84 CM DF4 MR EN
00763000643539 - OmniaSecure™ MRI SureScan™2025-12-29 LEAD 3930M64 US MKT 64 CM DF4 MR EN
00199150064052 - NA2025-12-23 CUSTOM PACK BB1B62R41 HLN CHR LNNT
00199150064847 - NA2025-12-22 CUSTOM PACK BB12P57R3 HLO IOM FUS M
00199150064861 - NA2025-12-22 CUSTOM PACK BB12S99R1 EVL NEONAT

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