PRINCETON

Basic Information

• Brand Name: PRINCETON
• Primary DI: 00810158210370
• Version / Model: 19131-21
• Company Name: Princeton Medical Group, Inc.
• Labeler DUNS: 012857277
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-06
• Public Version: 1
• Public Version Date: 2024-03-14
• Public Version Status: New
• Public Device Record Key: 26f932f8-1f06-4f6c-bf3e-818a8f53468c

Device Description

RETRACTOR US ARMY DOUBLE ENDED PAIR FIG. 1 21X15MM / 40X15MM FIG. 2 25X15MM / 45X15MM 8.25"

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIG	Retractor, All Types	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35314	Periocular/lacrimal retractor, hand-held, reusable	A hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810158210370	GS1