AccessGUDID - DEVICE: Artificial Iris with Fiber (04049154000012)

GUDID

Device Identifier (DI) Information

Brand Name: Artificial Iris with Fiber
Version or Model: 95001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00095001
Company Name: HumanOptics AG

Primary DI Number: 04049154000012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 326947129 *Terms of Use

Device Description: The CustomFlex Artificial Iris is a prosthetic iris (the colored part of the eye around the pupil) made of thin, foldable medical-grade silicone. This device is custom-made and can be sized and colored for each individual patient. This with Fiber model has a polyester meshwork layer embedded in it to provide adequate tear strength to withstand suturing. The CustomFlex Artificial Iris can be used to treat congenital (genetic disorder in which the iris is completely or partially absent) and traumatic aniridia.It can also be used to treat iris defects due to other reasons or conditions, such as albinism, or surgical removal due to melanoma.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
60894	Implantable iris prosthesis	A sterile optical device intended to be implanted into the posterior chamber of the eye for the reconstruction of partial or total iris defects (congenital, traumatic, or degenerative). It may be constructed from a single or multiple component(s) and implanted during cataract surgery, or secondarily into the pseudophakic eye. It is made of synthetic material [e.g., polymethylmethacrylate (PMMA), silicone] and is available in a variety of sizes and/or colours.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
QBT	Artificial Iris

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P170039	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 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 12.8 Millimeter

Device Record Status

Public Device Record Key: d07b8d62-1613-484d-ac83-38c217e736c5
Public Version Date: October 10, 2019
Public Version Number: 1
DI Record Publish Date: October 02, 2019