AccessGUDID - DEVICE: Pro-Paks (10810003224450)

GUDID

Device Identifier (DI) Information

Brand Name: Pro-Paks
Version or Model: 2002PL
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2002PL
Company Name: MICROSPECIALITIES, INC.

Primary DI Number: 10810003224450
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 013469890 *Terms of Use

Device Description: Post Refractive Shield sunglasses, 20 per box

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):	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: 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: bec5b53b-313f-4da7-8e37-e93c9b86904d
Public Version Date: June 19, 2024
Public Version Number: 2
DI Record Publish Date: September 02, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30810003224454	20	10810003224450		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00810003224453 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 203-874-1832
Email: customerservice@pro-paks.com

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