UNI-CLIP

Basic Information

• Brand Name: UNI-CLIP
• Primary DI: 10381780052609
• Version / Model: 213216ND
• Catalog Number: 213216ND
• Company Name: NEWDEAL
• Labeler DUNS: 536935331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-10-09
• Public Version: 7
• Public Version Date: 2023-05-22
• Public Version Status: Update
• Public Device Record Key: 07875419-237e-42f4-904a-5df98ed71641
• Distribution End Date: 2027-12-31

Device Description

The UNI-CLIP STAPLE is designed 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 sizes (11, 12, 13 or 15mm interaxis, and lengths vary from 13 to 20mm). The UNI-CLIP STAPLE is made from Stainless Steel and it is indicated for fixation of bone fractures or for bone reconstruction. It is delivered non sterile.

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: No
• PM Exempt: No
• 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
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
Primary	10381780052609	GS1
Secondary	M248213216ND1	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			11.25mm interaxis x 13.5mm length x 16mm height

Storage Conditions

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