NA

Basic Information

• Brand Name: NA
• Primary DI: 30381780125826
• Version / Model: DFUSTAPLERKIT
• Catalog Number: DFUSTAPLERKIT
• Company Name: Integra Lifesciences Corporation
• Labeler DUNS: 083171244
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 3
• Record Status: Published
• Publish Date: 2016-05-11
• Public Version: 6
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: a344a4d2-0f6c-4b4c-ae44-77bb5b0d0426

Device Description

Box of 3 Disposable Skin Staplers

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: 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
GDT	Staple, Removable (Skin)	General, Plastic Surgery	878.4760	1
GAG	Stapler, Surgical	General Hospital	878.4740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35884	Skin stapler/staple, non-bioabsorbable	A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30381780125826	GS1
Unit of Use	00381780125825	GS1

Customer Contacts

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