Dugel Entry Plate

Basic Information

• Brand Name: Dugel Entry Plate
• Primary DI: 00632307001543
• Version / Model: PD490.23
• Company Name: PEREGRINE SURGICAL, LTD.
• Labeler DUNS: 622467348
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-06
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 1b88c16d-a8ec-452f-a197-f3f00f135d31

Device Description

Dugel Entry Plate

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
HNH	RING, OPHTHALMIC (FLIERINGA)	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47364	General-purpose ophthalmic hook, single-use	A hand-held manual surgical instrument intended to facilitate the manipulation of ocular structures or to remove foreign bodies in the eye. It is typically shaft-like with a small curve (blunt- or pointed-end) or bend distally, and a handle proximally. The device is commonly used to retract eye muscles or to stabilize and manoeuver tissue during posterior segment surgery. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00632307001543	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]