AccessGUDID - DEVICE: NA (00643169510487)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 3550-68
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: MEDTRONIC, INC.

Primary DI Number: 00643169510487
Issuing Agency: GS1
Commercial Distribution End Date: May 24, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 796986144 *Terms of Use

Device Description: ACCY 3550-68 TWST LOCK SCREEN CABLE ROHS

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:	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?
44063	Neurosurgical procedure kit, non-medicated, single-use	A collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MFR	Stimulator, brain, implanted, for behavior modification
OLM	Deep brain stimulator for obsessive compulsive disorder (OCD)
NHL	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
MRU	implanted subcortical electrical Stimulator (motor disorders)
MHY	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
PJS	Stimulator, electrical, implanted, for essential tremor
MBX	Stimulator, thalamic, epilepsy, implanted

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P960009	220

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6364fbe1-3246-4587-964b-5268be529b17
Public Version Date: July 12, 2023
Public Version Number: 4
DI Record Publish Date: October 02, 2015

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: Yes
Serial Number: No
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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