AccessGUDID - DEVICE: NA (00613994752178)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 3625
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00613994752178
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796986144 *Terms of Use

Device Description: ACC 3625 SCREENER BEI REDESIGN US MKT

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
36175	Sacral plexus implantable incontinence-control electrical stimulation system	An assembly of battery-powered devices intended to treat urinary and/or faecal incontinence through the application of electrical stimuli to the muscles and/or neural tissue of the pelvic floor/bladder. It consists of an electrode implanted on or in the vicinity of the sacral plexus, a pulse generator with a receiver typically implanted in the abdomen/pelvic region, and an external programmer/transmitter that communicates with the implanted receiver.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MRU	implanted subcortical electrical Stimulator (motor disorders)
MHY	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
EZW	Stimulator, electrical, implantable, for incontinence
GZF	STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)
LGW	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
MFR	Stimulator, brain, implanted, for behavior modification
NHL	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
OLM	Deep brain stimulator for obsessive compulsive disorder (OCD)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080025	020
P840001	178
P960009	108
P970004	104

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 82a9cffc-dbc8-4287-ba05-5ba93c5a173b
Public Version Date: April 06, 2020
Public Version Number: 4
DI Record Publish Date: September 23, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES