De Soutter Medical

Basic Information

• Brand Name: De Soutter Medical
• Primary DI: 05051471032545
• Version / Model: 7680
• Catalog Number: 7680
• Company Name: DE SOUTTER MEDICAL LIMITED
• Labeler DUNS: 458064144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-25
• Public Version: 1
• Public Version Date: 2022-12-05
• Public Version Status: New
• Public Device Record Key: 2b854647-db50-4545-8724-fd5d458e8346

Device Description

PLASTER SHEAR

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGH	Instrument, Cast Removal, Ac-Powered	Orthopedic	888.5960	1

GMDN Terms

Code	Name	Definition	Implantable	Status
16341	Cast cutting shears	A large, scissors-like, hand-held instrument whose blades distal to the pivot point terminate in various jaw configurations, capable of cutting heavy layers of plaster or synthetic material used to form hardened casts, i.e., that which has already been used to form a cast around a patient's limb or body part. The tip of one of the distal blades forming the scissors-like cutting mechanism is usually rounded along it bottom edge to prevent injury to the patient as the cast is cut. This device is typically made of high-grade stainless steel and will usually be provided with a spring mechanism to assist in opening the jaws. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05051471032545	GS1