DeRoyal

Basic Information

• Brand Name: DeRoyal
• Primary DI: 00749756568197
• Version / Model: 25-3003
• Catalog Number: 25-3003
• Company Name: DEROYAL INDUSTRIES, INC.
• Labeler DUNS: 096372255
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-29
• Public Version: 1
• Public Version Date: 2021-07-07
• Public Version Status: New
• Public Device Record Key: e6ac4423-a3f0-470d-8335-bf2abf70badd

Device Description

Deluxe Skin Stapler 35W

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: Yes
• 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
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
Package	50749756568192	GS1	Case	30	In Commercial Distribution
Primary	00749756568197	GS1
Package	30749756568198	GS1	Box	6	In Commercial Distribution

Customer Contacts

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