FABCO

Basic Information

• Brand Name: FABCO
• Primary DI: 30634303021052
• Version / Model: 452350
• Catalog Number: 452350
• Company Name: FIRST AID BANDAGE CO INC
• Labeler DUNS: 001137280
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2019-03-15
• Public Version: 1
• Public Version Date: 2019-03-25
• Public Version Status: New
• Public Device Record Key: 36521a0e-d895-409b-abf3-a415e01e3fa0

Device Description

Flex-O-Blade

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMA	Depressor, Tongue, Non-Surgical	General Hospital	880.6230	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42461	Tongue depressor, examination, single-use	A hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30634303021052	GS1
Unit of Use	00634303021051	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	5.38	Inch