Swann Morton Ltd.

Basic Information

• Brand Name: Swann Morton Ltd.
• Primary DI: 05033955058210
• Version / Model: PD 81 STERILE SURGICAL BLADES
• Catalog Number: 5821
• Company Name: SWANN-MORTON LIMITED
• Labeler DUNS: 212397483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2022-05-13
• Public Version: 1
• Public Version Date: 2022-05-23
• Public Version Status: New
• Public Device Record Key: 45a6b596-2c7e-43d7-b776-ea47694c3fe3

Device Description

Blade,scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be attached to the scalpel handle. It is capable of cutting through tissue when moved with downward pressure. This device is disposable.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
GES	Blade, Scalpel	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37445	Manual scalpel blade, single-use	An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. It is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. Safety mechanisms (e.g., a retractable protective guard made of plastic) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05063043058211	GS1
Primary	05033955058210	GS1

Customer Contacts

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