FABCO

Basic Information

• Brand Name: FABCO
• Primary DI: 30634303800459
• Version / Model: Q606108
• Catalog Number: Q606108
• Company Name: FIRST AID BANDAGE CO INC
• Labeler DUNS: 001137280
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-05
• Public Version: 1
• Public Version Date: 2018-04-05
• Public Version Status: New
• Public Device Record Key: 7004982e-e818-4624-b1bf-2b70d190b7cf

Device Description

Femoral Canal Sponge 8 in

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: No
• 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
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	878.4450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47738	Femoral canal sponge	A long, slender, sterile sponge designed to be inserted into the surgically-opened femoral canal to absorb blood and irrigation fluids prior to the insertion of orthopaedic cement and a hip prosthesis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50634303800453	GS1	Dispenser Box	5	In Commercial Distribution
Primary	30634303800459	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Height	20	Millimeter
Width	28	Millimeter
Length	20	Centimeter