ACC 7440 ISTIM PROG ANT23.0LG Medical Device Identification

GUDID 10681490164594

ACC 7440 ISTIM PROG ANT23.0LG

MEDTRONIC, INC.

Multiple active implantable device programmer

Primary Device ID	10681490164594
NIH Device Record Key	d1649ce7-6462-48f7-9ef6-dd6ec2d35482
Commercial Distribution Discontinuation	2018-08-13
Commercial Distribution Status	Not in Commercial Distribution
Version Model Number	7440
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	false
Lot Batch	true
Serial Number	false
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
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
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	23 Inch
Length	58 Centimeter
Length	23 Inch
Length	58 Centimeter
Length	23 Inch
Length	58 Centimeter
Length	23 Inch
Length	58 Centimeter
Length	23 Inch
Length	58 Centimeter
Length	23 Inch
Length	58 Centimeter
Length	23 Inch
Length	58 Centimeter
Length	23 Inch
Length	58 Centimeter
Length	23 Inch
Length	58 Centimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10681490164594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Approval: P970004

FDA Product Code

EZW	Stimulator, electrical, implantable, for incontinence

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	6
Public Version Date	2020-07-07
Device Publish Date	2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00763000432973 - Vectris™	2024-08-12 LEAD 977D160 TRIALING MRICS SBCMPCT EMAN
00763000432980 - Vectris™	2024-08-12 LEAD 977D260 TRIALING MRICS COMPACT EMAN
00763000964603 - NA	2024-08-12 CUSTOM PACK BB12H12R2 ADULT TABLE P
20763000967110 - NA	2024-08-12 CUSTOM PACK BB12H25R 5PK 1/8 IN M/M
00763000967451 - NA	2024-08-12 CUSTOM PACK BB12H59R UCHICAGOCPB3/8
00763000967482 - NA	2024-08-12 CUSTOM PACK BB11M88R16 CARDIOHELP P
00763000946395 - DLP®	2024-08-12 ADAPTER 10001 STRAIGHT 20PK 17L
00763000946517 - DLP®	2024-08-12 CANNULA 70420 ART FLEX ARCH 20FR 20P 17L