25GA Membrane Scraper

Basic Information

• Brand Name: 25GA Membrane Scraper
• Primary DI: 00632307002281
• Version / Model: 1290.S25-00
• Company Name: PEREGRINE SURGICAL, LTD.
• Labeler DUNS: 622467348
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-05-10
• Public Version: 1
• Public Version Date: 2023-05-18
• Public Version Status: New
• Public Device Record Key: 61013bde-528b-46ae-b8d8-9aee6cf6ce24

Device Description

25GA Membrane Scraper

Device Characteristics

• Single Use: Yes
• 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: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63432	Epiretinal/inner limiting membrane scraper, single-use	A hand-held manual surgical instrument intended to be used during posterior segment surgery to lift the inner limiting membrane (ILM) and/or an epiretinal membrane (ERM), and which may have additional posterior segment membrane manipulation uses. It includes a dedicated textured tip (e.g., diamond-dusted polymer) intended to effectively grip/lift the membrane for further manipulation (e.g., with forceps); it may additionally include non-powered features (e.g., fibreoptics) to allow cold light to be directed to the surgical site. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00632307002281	GS1
Package	10632307002288	GS1	Box	5	In Commercial Distribution

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			25 Gauge Needle
Needle Gauge	25	Gauge