AccessGUDID - DEVICE: Eye Shield (M68906205050)

GUDID

Device Identifier (DI) Information

Brand Name: Eye Shield
Version or Model: 05
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 06-205
Company Name: Safeguard US Operating, LLC

Primary DI Number: M68906205050
Issuing Agency: HIBCC
Commercial Distribution End Date: October 13, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 118492643 *Terms of Use

Device Description: 1ea - 2.375" x 3", polycarbonate eye shield w/garter 3ea - 0.875" x 2.625" adhesive strips

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):	No
Over the Counter (OTC):	Yes
Kit:	Yes
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?
61490	Eye patch	A device intended to be used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention. It is made of a synthetic or biological material. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)

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: e8a1173b-c763-42fb-a857-037093180f65
Public Version Date: October 14, 2024
Public Version Number: 3
DI Record Publish Date: August 06, 2019