SafeTCount™

Basic Information

• Brand Name: SafeTCount™
• Primary DI: 20809160023140
• Version / Model: 3200
• Company Name: MEDICAL ACTION INDUSTRIES INC.
• Labeler DUNS: 092364462
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-08-20
• Public Version: 3
• Public Version Date: 2019-11-27
• Public Version Status: Update
• Public Device Record Key: 8df99d08-f81d-4f36-9642-b3d1a63fec39

Device Description

Glove: Sponge Ct 500/cs

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
LWH	Counter, sponge, surgical	General Hospital	880.2740	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13693	Surgical sponge-counting rack	A device in the form of a vertically-mounted rack intended to be used in the operating room (OR) to maintain the count of surgical sponges/swabs during a surgical procedure, typically to prevent these items from being inadvertently left in a patient. It is a rack/holder with hooks/pockets upon which soiled sponges/swabs may be arranged; it may be used in conjunction with an associated counting bag (not included). This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30809160023147	GS1		5	In Commercial Distribution
Primary	20809160023140	GS1
Unit of Use	10809160023143	GS1