AccessGUDID - DEVICE: SILICONE CONFORMER (FLEXIBLE) (03760087122589)

GUDID

Device Identifier (DI) Information

Brand Name: SILICONE CONFORMER (FLEXIBLE)
Version or Model: S6.2001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FCI S A S FCI 20 22

Primary DI Number: 03760087122589
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 763408366 *Terms of Use

Device Description: 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.

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: 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: 9068b761-a168-490e-a2c9-fe8f06746d31
Public Version Date: June 07, 2021
Public Version Number: 1
DI Record Publish Date: May 30, 2021