AccessGUDID - DEVICE: Ophthalmic conformer (03760087122749)

GUDID

Device Identifier (DI) Information

Brand Name: Ophthalmic conformer
Version or Model: PERFORATED CONFORMER MEDIUM SIZE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S6.2231U
Company Name: FCI S A S FCI 20 22

Primary DI Number: 03760087122749
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: Yes

Sterilization Method [?]
Radiation Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 25.2 Millimeter
Width: 22 Millimeter

Device Record Status

Public Device Record Key: 418d97dc-4354-4d16-835c-d4af2088b7a0
Public Version Date: March 16, 2020
Public Version Number: 1
DI Record Publish Date: March 06, 2020