AccessGUDID - DEVICE: Intacs for Keratoconus, Symmetric 0.350 mm (00850048576131)

GUDID

Device Identifier (DI) Information

Brand Name: Intacs for Keratoconus, Symmetric 0.350 mm
Version or Model: ICI-350-150
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 11600-350-150
Company Name: ADDITION TECHNOLOGY, INC.

Primary DI Number: 00850048576131
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118496814 *Terms of Use

Device Description: Intacs Corneal Implants are designed to reshape the anterior curvature of the cornea for the reduction or elimination of myopia and astigmatism in patients with keratoconus. The medical device consists of two clear 150-degree arc segments and are available in sizes from 0.210 to 0.450 mm.

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):	No
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?
46903	Intracorneal ring segment	An implantable arc designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct certain corneal-related visual disorders. It is typically a plastic arc, of about 150 degrees and provided in pairs, inserted into the cornea via an intrastromal channel created with a diamond knife or laser, and that can be implanted away from the radial incision to minimize complications. It is typically available in sizes from 0.25 to 0.35 mm. The device is intended to correct mild and moderate myopia and to treat patients with irregular astigmatism as a result of keratoconus, especially those who can no longer benefit from contact lenses or spectacles.	Active	true
36291	Intracorneal ring	An implantable, open-ended circular band designed to flatten the anterior corneal curvature, without disturbing the visual axis, to correct mild and moderate myopia. The device is inserted into the cornea via an intrastromal channel created with a diamond knife or laser. It is typically made of plastic, and has outer and inner diameters of about 8 and 6.8 mm, respectively.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LQE	Implant, Corneal, Refractive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
H040002	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ab5dfc63-e64b-425c-b68a-62595b2114a8
Public Version Date: June 21, 2023
Public Version Number: 1
DI Record Publish Date: June 13, 2023