AccessGUDID - DEVICE: NA (05415067045713)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 12710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 12710
Company Name: ADVANCED NEUROMODULATION SYSTEMS, INC.

Primary DI Number: 05415067045713
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021675699 *Terms of Use

Device Description: Port Plug

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?
44900	Implantable pulse generator port plug	A non-active implantable device designed for insertion into the vacant/unused connector port of an implantable pulse generator (e.g., cardiac pacemaker/defibrillator, neurostimulator) to seal and electrically isolate the port, and to protect the parent device. It is typically made of metal and/or polymer materials; disposable devices intended to facilitate connection/stabilisation (e.g., torque wrench) may be included with the port plug.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PJS	Stimulator, electrical, implanted, for essential tremor
NHL	Stimulator, electrical, implanted, for parkinsonian symptoms
MHY	Stimulator, electrical, implanted, for parkinsonian tremor
LGW	Stimulator, spinal-cord, totally implanted for pain relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010032	186
P140009	087

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: more than 73 Degrees Fahrenheit
Storage Environment Temperature: more than 23 Degrees Celsius
Special Storage Condition, Specify: Excursion Temperature Limits: -20°C to 60°C. Long term storage temperature 23°C (73°F)

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1d5d08dd-bf6f-4a2a-a7f8-fa91e9e1f0a0
Public Version Date: January 10, 2025
Public Version Number: 3
DI Record Publish Date: January 04, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
15415067045710	2	05415067045713		In Commercial Distribution

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(855)478-5833
Email: customerservice@sjm.com

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