MICROTEK

Basic Information

• Brand Name: MICROTEK
• Primary DI: 00748426077540
• Version / Model: 1
• Company Name: Microtek Medical Inc.
• Labeler DUNS: 106908437
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-16
• Public Version: 4
• Public Version Date: 2023-03-22
• Public Version Status: Update
• Public Device Record Key: f24726ce-eb4f-4e4f-9053-56445360030d

Device Description

PACEMAKER/EP DRAPE W/MICROBAN & DUAL FC POUCHES, 100 X 144, 1-EACH

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KKX	Drape, surgical	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47801	Subcutaneous self-injection aid	A device designed to be used by a layperson to self-administer a subcutaneous injection, typically by a person who has difficulty with painless self-injections [e.g., patients with rheumatoid arthritis (RA)]. It is typically in the form of a tube or container in which a prefilled syringe assembly (syringe with medication and needle) is placed and secured; the user grips the device, places it on the body surface at the injection site, and presses the plunger of the syringe to inject the medication. The device may also enable needle penetration at an appropriate angle (typically 90° to the body surface) and to a pre-set depth. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50748426077545	GS1		20	In Commercial Distribution
Primary	00748426077540	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store under normal warehouse conditions.