AccessGUDID - DEVICE: EXTERNAL OCULID TAN®

GUDID

Device Identifier (DI) Information

Brand Name: EXTERNAL OCULID TAN® - 0,6 g
Version or Model: S3.60062
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FCI S A S FCI 20 22

Primary DI Number: 13700773727619
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 763408366 *Terms of Use

Device Description: EXTERNAL OCULID TAN® - 0,6 g

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
18142	Eyelid weight, external	An ophthalmic device that is applied to the outside of the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device can be used for: 1) the treatment of temporary facial paralysis caused by Bell's palsy, trauma, or a stroke; or 2) to determine the appropriate size of implantable eyelid weights prior to surgery. This device uses gravity to gently close the upper eyelid when blinking or when the eyelid muscle is relaxed, and is made of a heavy material (e.g., tantalum). It is worn just above the eyelashes, adhered to the skin with double-sided adhesive tape, and is coloured in a variety of skin shades (pink, tan, brown, dark brown).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MML	Weights, Eyelid, External

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: 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: f285eb88-477d-4e7a-8289-8820aecba760
Public Version Date: March 16, 2022
Public Version Number: 1
DI Record Publish Date: March 08, 2022