Pergo

Basic Information

• Brand Name: Pergo
• Primary DI: 08681756010028
• Version / Model: 05TD0012
• Company Name: PERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETI
• Labeler DUNS: 533130347
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2025-06-30
• Public Version: 1
• Public Version Date: 2025-07-08
• Public Version Status: New
• Public Device Record Key: 42f8beb3-6ace-4b44-9bf1-fe6410250a01

Device Description

Eye Safety Tape Adult

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMP	Pad, Eye	General, Plastic Surgery	878.4440	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65732	Postsurgical eye shield, hermetic	A device designed to be worn over the eye to protect the eye while maintaining a sealed moisture chamber, typically following LASIK surgery or in the case of lagophthalmos. It is designed as a transparent or opaque self-adhesive dome intended to create an airtight chamber around the eye. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08681756010028	GS1
Unit of Use	08681756010042	GS1