AccessGUDID - DEVICE: Argus II Retinal Prosthesis Retinal Tacks (10856264005322)

GUDID

Device Identifier (DI) Information

Brand Name: Argus II Retinal Prosthesis Retinal Tacks
Version or Model: 011006-001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 011006
Company Name: Second Sight Medical Products, Inc.

Primary DI Number: 10856264005322
Issuing Agency: GS1
Commercial Distribution End Date: March 31, 2023
Device Count: 2
Labeler D-U-N-S® Number*: 086470742 *Terms of Use

Device Description: The Argus II Retinal Tack is used to affix the electrode array of the Retinal Prosthesis to the retina.

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?
57798	Retinal tack	A sterile, non-bioabsorbable, implantable device designed to permanently fix a detached retina to the underlying retinal pigment epithelium (RPE) during ophthalmic surgery. It typically includes a conical, sharply-pointed forward end portion, an elongated cylindrical retaining portion, including one or more peripheral grooves for receiving displaced sclera tissue, and an enlarged head with a flange portion for engaging the retina in the area of the opening formed in the retina; it is intended to be pierced through the retina, choroid membrane, and sclera. The device is typically made of titanium (Ti), surgical-grade stainless steel, or a synthetic material.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NBF	Prosthesis,Retinal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H110002	000

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 14 and 131 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ee264eb-f10f-48ea-be96-2b88f310a1c5
Public Version Date: May 18, 2023
Public Version Number: 4
DI Record Publish Date: December 16, 2014