AccessGUDID - DEVICE: InterStim™ Micro SureScan™ (00763000203849)

GUDID

Device Identifier (DI) Information

Brand Name: InterStim™ Micro SureScan™
Version or Model: 97810
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00763000203849
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 796986144 *Terms of Use

Device Description: INS 97810 ISTM MICRO SSMRI RC EMAN US

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
61391	Implantable incontinence-control electrical stimulation system pulse generator	A sterile, hermetically-sealed, battery-powered component of an implantable incontinence-control pelvic electrical stimulation system, intended to be implanted beneath the skin (e.g., upper buttock area) to produce electrical signals for the treatment of chronic disorders of the pelvis and lower urinary or intestinal tract typically related to urinary and/or faecal incontinence (including non-obstructive urinary retention and overactive bladder). The electrical signals are delivered to the sacral nerve plexus via implantable electrodes (not included), and the pulse generator may be controlled by an external programmer.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
EZW	Stimulator, electrical, implantable, for incontinence

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080025	197
P970004	302

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 47fe6aea-3f17-475d-a299-d0df4720f998
Public Version Date: August 18, 2020
Public Version Number: 1
DI Record Publish Date: August 10, 2020

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

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