SkinPlus

Basic Information

• Brand Name: SkinPlus
• Primary DI: 04717480906024
• Version / Model: DP0S1-SR
• Company Name: TAIWAN SURGICAL CORPORATION
• Labeler DUNS: 657134172
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-11
• Public Version: 1
• Public Version Date: 2023-07-19
• Public Version Status: New
• Public Device Record Key: 9d63f227-2b35-4809-8ff6-2241e1a4bd6c

Device Description

Disposable Skin Stapler, Regular, 35 staples

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: No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QQS	Stapler, Skin	General Hospital	878.4740	1

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	04717480906024	GS1