AccessGUDID - DEVICE: Autoclavable Plastic Ocular Shield, bilateral, medium, black with handle (10697660002979)

GUDID

Device Identifier (DI) Information

Brand Name: Autoclavable Plastic Ocular Shield, bilateral, medium, black with handle
Version or Model: 23-204BHE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Oculo-Plastik Inc

Primary DI Number: 10697660002979
Issuing Agency: GS1
Commercial Distribution End Date: March 24, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 257382580 *Terms of Use

Device Description: The plastic ocular shields are used to protect the eyes when working with a scalpel, electro-cutter or other energy sources requiring protective plastic shields as the metal would be conductive (ex: RF system). The ocular shields are inserted under the eyelids over the globe, and remain in place for the duration of the intervention. They should not be left in place more than 60 minutes. PLASTIC OCULAR SHIELDS ARE NOT INTENDED FOR USE WITH LASER OR IPL SYSTEMS.

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	No
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?
64271	Radiation/mechanical corneal shield, reusable	A protective device intended to be placed on the cornea of a patient to protect the eyes from physical damage and/or exposure to primary and scattered radiation during a medical procedure [e.g., periorbital surgery, x-ray/CT scan, dermatological laser treatment]. It is typically in the form of a dome and is made of non-biodegradable, durable materials (e.g., lead, tungsten, glass, plastic) that provide mechanical protection and/or prevent the transmission of harmful radiation to the eyes. This is a reusable 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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 27 Millimeter
Width: 24 Millimeter

Device Record Status

Public Device Record Key: 93b4837f-d82e-49bc-a3c0-416561c456fc
Public Version Date: March 25, 2022
Public Version Number: 2
DI Record Publish Date: November 05, 2019