Large UNI-CLIP

Basic Information

• Brand Name: Large UNI-CLIP
• Primary DI: 10381780052814
• Version / Model: 314827SND
• Catalog Number: 314827SND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 5
• Public Version Date: 2021-11-23
• Public Version Status: Update
• Public Device Record Key: 852f2d5a-c8f7-40f2-9c16-c0f596d29f52
• Distribution End Date: 2018-10-22

Device Description

The LARGE UNI-CLIP STAPLE is a staple so that, by widening the diamond shaped opening, mechanical deformation leads to narrowing of the interaxis of the two legs. The surgeon can obtain a true compression, adjustable and controlled with many choice of size (20mm or 25mm interaxis and lengths vary from 20 to 32mm). The LARGE UNI-CLIP STAPLE is made from Stainless Steel and it is indicated for fixation of bone fractures or for bone reconstruction. It is delivered sterile.

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: No
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDR	STAPLE, FIXATION, BONE	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61669	Orthopaedic bone staple, non-adjustable	A non-bioabsorbable, implantable device designed to be inserted into fractured bone to achieve fixation and repair; the device may also be used to attach/secure structures (e.g., ligaments/tendons) to bone, or to reduce/cease bone growth in skeletal deformities (e.g., by being implanted across epiphysial cartilage). It is typically a curved or U-shaped device made of metal alloy material, and is not adjustable after it has been applied. Guides for drilling integrated into the handle of the staple and disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M248314827SND1	HIBCC
Primary	10381780052814	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K061594	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			25mm interaxis x 27/32mm height

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in dry place.