LEAD 3778-75 OCTAD 1X8 LZ 4MM SP EN eMAN Medical Device Identification

GUDID 00613994721952

LEAD 3778-75 OCTAD 1X8 LZ 4MM SP EN eMAN

MEDTRONIC, INC.

Neural-tissue electrical stimulation lead Neural-tissue electrical stimulation lead Spinal cord/peripheral nerve implantable analgesic electrical stimulation system lead, wired connection

Primary Device ID	00613994721952
NIH Device Record Key	8ffbdd47-fe53-4ef7-8e61-aba548723e42
Commercial Distribution Status	In Commercial Distribution
Version Model Number	3778-75
Company DUNS	796986144
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Dimensions

Length	75 Centimeter
Length	75 Centimeter
Length	75 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius
Storage Environment Temperature	Between -30 Degrees Fahrenheit and 135 Degrees Fahrenheit
Storage Environment Temperature	Between -34 Degrees Celsius and 57 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994721952 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P840001

FDA Product Code

LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00763000894689 - SHERPA NX BALANCED™	2024-06-07 CATHETER SB6MP1K SB 6F 55CM MP1
00763000894726 - SHERPA NX BALANCED™	2024-06-07 CATHETER SB6MPHK SB 55CM MPH
00763000894801 - SHERPA NX BALANCED™	2024-06-07 CATHETER SB6PK1W SB 6F 47CM PK1
00763000894917 - SHERPA NX BALANCED™	2024-06-07 CATHETER SB6RDCK SB 6F 55CM RDC
00763000895754 - SHERPA NX BALANCED™	2024-06-07 CATHETER SB7IMAK SB 7F 55CM IMA
00763000901905 - Launcher™	2024-06-07 CATHETER LA8NOTOSH LA 8F 100CM NOTO
00763000902230 - Launcher™	2024-06-07 CATHETER LA8SCR35SH LA 8F 100CM SCR35
00763000902520 - Launcher™	2024-06-07 CATHETER LA83DRC LA 8F 100CM 3DRC