AccessGUDID - DEVICE: STERILE PermaLoc Electrode, 60cm (00852184003144)

GUDID

Device Identifier (DI) Information

Brand Name: STERILE PermaLoc Electrode, 60cm
Version or Model: 21-0017-99
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Synapse Biomedical, Inc.

Primary DI Number: 00852184003144
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 138432070 *Terms of Use

Device Description: No description.

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:	Yes
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?
47810	Intramuscular diaphragm/phrenic nerve electrical stimulation system electrode, active	A sterile implanted active wire, insulated with non-conductive material except at its electrode(s), used as part of an intramuscular diaphragm/phrenic nerve electrical stimulation system to conduct electrical current from an external pulse generator (EPG) to the phrenic nerve motor point in the diaphragm, to contract the diaphragm rhythmically and cause the patient to draw breath in a manner similar to natural breathing. The distal end of the electrode is embedded into the muscle tissue, and the proximal end protrudes percutaneously to connect to the external pulse generator (EPG) via a cable.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OIR	Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: c4552130-a976-4c1b-8394-e194be59d25f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2014