HK Sterile Super Absorbent OR Table Sheet 31"x 48"

Basic Information

• Brand Name: HK Sterile Super Absorbent OR Table Sheet 31"x 48"
• Primary DI: 00816989020843
• Version / Model: SPD-OR3148
• Catalog Number: SPD-OR3148
• Company Name: HK SURGICAL INC.
• Labeler DUNS: 106885259
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2017-12-22
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 8bbd306b-498b-436a-9101-6c27915a919c

Device Description

HK Sterile Super Absorbent OR Table Sheet 31"x 48"

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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRL	Fiber, Medical, Absorbent	General Hospital	880.5300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61849	Absorbent underpad, sterile	A sterile flat piece of absorbent fabric material [e.g., non-woven polyethylene (PE), cellulose] intended to be placed on a surface (e.g., bed mattress, table, floor) and underneath a patient to absorb bodily fluids resulting from surgical procedures or incontinence. It is intended to be used in the healthcare facility and in the home. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816989020843	GS1
Unit of Use	10816989020840	GS1

Customer Contacts

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