LARGE UNI-CLIP®

Basic Information

• Brand Name: LARGE UNI-CLIP®
• Primary DI: 10381780044680
• Version / Model: 119314ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-26
• Public Version: 3
• Public Version Date: 2019-03-19
• Public Version Status: Update
• Public Device Record Key: ee86c40c-e316-4a58-9cae-db254b3e7ee5
• Distribution End Date: 2018-10-22

Device Description

The spreading forceps is used to generate compression to achieve fixation. Placed in the diamond of the staple, by squeezing the diamond will expand and the staple legs will come together in a parallel manner.

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
HTD	FORCEPS	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44539	Surgical flat-nosed pliers	A heavy-duty, surgical instrument with specially designed sturdy handles and gripping jaws (typically parallel) used to grip and hold an object during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248119314ND1	HIBCC
Primary	10381780044680	GS1

Customer Contacts

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