AccessGUDID - DEVICE: Small Conformer (non-sterile) (B091141641)

GUDID

Device Identifier (DI) Information

Brand Name: Small Conformer (non-sterile)
Version or Model: 14164
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14164
Company Name: Gulden Ophthalmics Inc.

Primary DI Number: B091141641
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 002373249 *Terms of Use

Device Description: Conformer is temporarily implanted between the eye ball and the eye lid to protect sutures and to prevent adhesion of the eye lid onto the eye sac. The Conformer also prevents the orbital socket from closing in on itself during the healing process and forces the muscles to conform around it.

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?
16065	Ophthalmic conformer	An ophthalmic device, typically constructed from moulded plastic, that is intended to be inserted temporarily between the eyeball and eyelid to maintain space in the orbital cavity and prevent closure or adhesions during the healing process following eye surgery. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQN	Conformer, Ophthalmic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 0.87 Inch
Length: 0.75 Inch

Device Record Status

Public Device Record Key: 14f9763c-51de-48cf-89ed-7febceabeb52
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016