GUDID 00763000719319

CABLE 05116 STERILE GLBL

MEDTRONIC, INC.

Electrical-only medical device connection cable, reusable
Primary Device ID00763000719319
NIH Device Record Key8238a2cc-034f-46e2-9f23-fdf4b1c40bc8
Commercial Distribution StatusIn Commercial Distribution
Version Model Number05116
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 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
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

Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter
Length366 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000719319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPBCardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-30
Device Publish Date2024-08-22

Devices Manufactured by MEDTRONIC, INC.

00199150021055 - NA2025-06-06 CUSTOM PACK BB11B15R1 CHP CIRCUIT
00199150021062 - NA2025-06-06 CUSTOM PACK BB11F90R3 ADULT ECC3/8
00199150021079 - NA2025-06-06 CUSTOM PACK BB7C59R10 E C L S
20199150021110 - NA2025-06-06 CUSTOM PACK BB6X07R3 2PK 38 E
20199150021134 - NA2025-06-06 CUSTOM PACK BB12A97R1 5PK PIGTAIL
00199150021147 - NA2025-06-06 CUSTOM PACK BB10Z01R17 SUPPORT PACK
20199150021165 - NA2025-06-06 CUSTOM PACK BB10Y40R1 5PK BRIDGE PACK
20199150021653 - NA2025-06-06 CUSTOM PACK BB12D52R2 10PK 3/16 BRIDGE

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