Medical Action Industries

Basic Information

• Brand Name: Medical Action Industries
• Primary DI: 10809160021040
• Version / Model: 75178
• Company Name: MEDICAL ACTION INDUSTRIES INC.
• Labeler DUNS: 092364462
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-20
• Public Version: 3
• Public Version Date: 2021-11-15
• Public Version Status: Update
• Public Device Record Key: 8edcc7a9-6d68-42ea-8ec4-1dc67e74920e
• Distribution End Date: 2021-11-12

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MLT	Pelvic exam kit	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34122	Pelvic examination kit	A collection of sterile devices designed to perform a pelvic examination. It contains all of the various instruments, specimen collection materials, and pharmaceuticals necessary for this procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20809160021047	GS1		50	Not in Commercial Distribution	2021-11-12
Primary	10809160021040	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Type: Special Storage Condition, Specify
• Special Conditions: store at room temperature