Getinge Pack Self-Seal Sterilization Pouch 33cm x 46cm

Basic Information

• Brand Name: Getinge Pack Self-Seal Sterilization Pouch 33cm x 46cm
• Primary DI: 00814434020707
• Version / Model: 6005500050
• Catalog Number: 6005500050
• Company Name: STERITEC PRODUCT MFG. CO., INC.
• Labeler DUNS: 622223196
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2019-11-08
• Public Version Status: Update
• Public Device Record Key: e7d258d9-20ae-424e-a244-74bfe8d20ebc
• Distribution End Date: 2016-09-23

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: No
• 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
FRG	Wrap, Sterilization	General Hospital	880.6850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
13735	Sterilization packaging, single-use	A device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20814434020701	GS1	Case	1	Not in Commercial Distribution	2016-09-23
Package	10814434020704	GS1	Bag	200	Not in Commercial Distribution	2016-09-23
Primary	00814434020707	GS1

Premarket Submissions

Submission Number	Supplement Number
K152669	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 95 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: – 70 Percent (%) Relative Humidity