Synergetics

Basic Information

• Brand Name: Synergetics
• Primary DI: 10841305101064
• Version / Model: 18060
• Catalog Number: 18060
• Company Name: SYNERGETICS USA, INC.
• Labeler DUNS: 021056726
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-31
• Public Version: 1
• Public Version Date: 2020-06-08
• Public Version Status: New
• Public Device Record Key: e16be1fa-3050-44fa-91ac-8ea35ec84901

Device Description

I-PACK Injection Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20841305107544	GS1	Box	10	In Commercial Distribution
Primary	10841305101064	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 59 – 77 Degrees Fahrenheit