AccessGUDID - DEVICE: MSI Precision Specialty Instruments (00194613017101)

GUDID

Device Identifier (DI) Information

Brand Name: MSI Precision Specialty Instruments
Version or Model: 1770-100-PM8
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Med Saver, Inc.

Primary DI Number: 00194613017101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 556623486 *Terms of Use

Device Description: Universal Eye Shields Clear Plastic With 8 Holes 100 per Package

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:	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?
65733	Postsurgical eye shield, vented	A device designed to be worn over the eye to protect the eye following ophthalmic surgery; some types may in addition be used following injury/trauma. It is designed as a transparent or opaque dome with vent holes to allow air to circulate around the eye; it may be self-adhesive, or fixed by a strap or an adhesive dressing. 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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: b3e8d278-087c-40f8-b319-cac67b7b61a2
Public Version Date: August 23, 2024
Public Version Number: 1
DI Record Publish Date: August 15, 2024