AccessGUDID - DEVICE: Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depth (08717872004549)

GUDID

Device Identifier (DI) Information

Brand Name: Eckardt temporary keratoprosthesis, Ø 7 mm, 1.6mm depth
Version or Model: 1285.2
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1285.2
Company Name: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.

Primary DI Number: 08717872004549
Issuing Agency: GS1
Commercial Distribution End Date: April 12, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 407522184 *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:	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?
36054	Therapeutic contact lens	A soft ophthalmic lens, typically made of a synthetic polymer/silicone, designed to be temporarily applied directly to the front surface of the eye (globe or cornea) to treat and manage non-refractive disorders such as cataract-removal wounds, corneal damage, and dry eyes. The device, sometimes referred to as a bandage contact lens, may be used to protect the eyes after surgery to allow wound healing; to treat corneal irregularities, erosions, and persistent epithelial defects/ulcers; to seal the anterior chamber; to deliver drugs; or for other treatment purposes.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MLP	Keratoprosthesis, Temporary Implant, Surgical Use

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: bea72901-cf28-4c31-94ca-1f37d834edc8
Public Version Date: January 13, 2022
Public Version Number: 5
DI Record Publish Date: September 23, 2016