AccessGUDID - DEVICE: Clear Eye Shield (00813465012163)

GUDID

Device Identifier (DI) Information

Brand Name: Clear Eye Shield
Version or Model: 9402
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9402
Company Name: HURRICANE MEDICAL INC

Primary DI Number: 00813465012163
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 093377724 *Terms of Use

Device Description: Protects the eye during or after surgery, or after trauma. Universal for left or right eye.

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?
35063	Eye mask	A mechanical shield intended to be fitted over the eyes to prevent the intrusion of light, typically to facilitate rest or sleep in illuminated environments and/or at home. It typically consists of an external covering made of an opaque plastic, or other appropriate material, that does not allow the passage of light and that is lined with a padded inner liner (e.g., foam, gauze); it is held in place with a strap(s). It is intended for single-patient use.	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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Radiation Sterilization
Ethylene Oxide

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: 18722f21-8231-4372-a72a-c22f58d34868
Public Version Date: May 13, 2020
Public Version Number: 1
DI Record Publish Date: May 05, 2020