N/A

Basic Information

• Brand Name: N/A
• Primary DI: 04961333240937
• Version / Model: 74187
• Company Name: PENTAX OF AMERICA, INC.
• Labeler DUNS: 083211284
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2018-03-13
• Public Version: 1
• Public Version Date: 2018-04-13
• Public Version Status: New
• Public Device Record Key: e656bf9c-b938-4685-ae9f-d5fe6815cce1

Device Description

FILMPACK UPC-21L 4PACKSX50,4RIBBONS

Device Characteristics

• Single Use: Yes
• 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: 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
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	878.4160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61901	Medical printer paper	A thin sheet of fibrous material intended to be used to produce a hard copy of printed data/images generated by a medical device (e.g., laboratory instrument/analyser, electrocardiograph, x-ray imaging system, hospital printer). It is typically available as a continuous length of paper (e.g., roll or accordion) or as individual sheets of paper; some types are pre-treated with thermochromic ink for use with thermal printers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04961333240937	GS1
Unit of Use	14961333240934	GS1

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 0 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 0 – 30 Degrees Celsius