Swann Morton Ltd.

Basic Information

• Brand Name: Swann Morton Ltd.
• Primary DI: 05033955120504
• Version / Model: PARAGON STERILE SKIN GRAFT BLADES
• Catalog Number: PS50
• Company Name: SWANN-MORTON LIMITED
• Labeler DUNS: 212397483
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-05-30
• Public Version: 1
• Public Version Date: 2022-06-07
• Public Version Status: New
• Public Device Record Key: 7fd47b28-a33b-4a5e-93d2-3d4e9f070ddf

Device Description

Dermatome -A surgical instrument used for harvesting skin for grafting purposes.

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
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35134	Dermatome blade, single-use	A surgical cutting device that is designed to be mounted onto a dermatome handle/handpiece (not included) and used to provide the cutting edge for the harvesting of skin grafts or excision of small skin lesions. It is available in various sizes. 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	05063043120505	GS1
Primary	05033955120504	GS1

Customer Contacts

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