Amerisource Bergen

Basic Information

• Brand Name: Amerisource Bergen
• Primary DI: 00368001108034
• Version / Model: 10803
• Company Name: BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
• Labeler DUNS: 985523874
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-18
• Public Version: 3
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: 6146a126-2287-4126-8c13-f3289ffa3527

Device Description

Disposable Skin Stapler Remover

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47192	Skin staple remover, single-use	A hand-held manual surgical instrument intended to be used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a tweezers-like device made of metallic or synthetic polymer materials with blades at the distal end activated by lever action designed for grasping, opening, and removing surgical staples. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20368001108038	GS1	Inner Box	20	In Commercial Distribution
Primary	00368001108034	GS1
Package	60368001108036	GS1	Case	10	In Commercial Distribution