AccessGUDID - DEVICE: Argus ll Operating Room Coil (00856264005387)

GUDID

Device Identifier (DI) Information

Brand Name: Argus ll Operating Room Coil
Version or Model: 012103-003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 012103
Company Name: Second Sight Medical Products, Inc.

Primary DI Number: 00856264005387
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 086470742 *Terms of Use

Device Description: The operating room coil is used during surgery in replacement of the glasses. A telemetry coil and radio-frequency system are mounted on the device to provide communication between the implant and the VPU during surgery.

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?
58522	Retinal prosthesis system implantation test coil	A radio-frequency coil that is a component of a retinal prosthesis system designed for intraoperative testing of the implant. Typically it is used in the operating room (OR) by a surgeon or other healthcare personnel.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBF	Prosthesis,Retinal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H110002	003

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
Storage Environment Temperature: between 32 and 113 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dfa6440d-5ddd-4883-bad1-a20a3c23db42
Public Version Date: May 18, 2023
Public Version Number: 4
DI Record Publish Date: May 06, 2015