Amerisource Bergen

Basic Information

• Brand Name: Amerisource Bergen
• Primary DI: 00368001108010
• Version / Model: 10801
• Company Name: BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
• Labeler DUNS: 985523874
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 35
• Record Status: Published
• Publish Date: 2021-11-18
• Public Version: 3
• Public Version Date: 2022-08-11
• Public Version Status: Update
• Public Device Record Key: d98f18c7-a45f-421f-8511-20012a620332

Device Description

Disposable Skin Stapler 35W

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
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
Package	20368001108014	GS1	Inner Box	5	In Commercial Distribution
Primary	00368001108010	GS1
Package	60368001108012	GS1	Case	20	In Commercial Distribution
Unit of Use	80368001108016	GS1