AccessGUDID - DEVICE: Upper Eyelid Implant Platinum/Iridium (EHKM40070021)

GUDID

Device Identifier (DI) Information

Brand Name: Upper Eyelid Implant Platinum/Iridium
Version or Model: 4007002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4007002
Company Name: Heinz Kurz GmbH

Primary DI Number: EHKM40070021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341155720 *Terms of Use

Device Description: Eyelid weight, implantable

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
18074	Eyelid weight, implantable	An ophthalmic device that is implanted subcutaneously within the upper eyelid to "lidload" the eyelid to restore upper eyelid muscle (musculus orbicularis oculi) function. This device is used for the treatment of lagophthalmos, a condition that frequently results from facial paralysis caused by Bell's palsy, trauma, a stroke, or as an indirect consequence of the surgical removal of certain types of tumour in close proximity to the facial nerve. 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., gold (Au), platinum (Pt)].	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MML	Weights, Eyelid, External

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K011115	000

Device Exempt from Premarket Submission: No 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: fd37eb6e-b2d4-4436-b9c1-e97110a8bdb9
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 21, 2015