ACE

Basic Information

• Brand Name: ACE
• Primary DI: 00614950000173
• Version / Model: 0038901
• Catalog Number: 0038901
• Company Name: ACE SURGICAL SUPPLY CO., INC.
• Labeler DUNS: 042763706
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-21
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7b0a4433-2b87-40ea-8d4f-38cd9ee95652

Device Description

PATIENT DRAPE FULL LENGTH 40X48 1/BAG 20/CASE STERILE

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: 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: Yes
• Sterilization Prior Use: No

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
47781	General-purpose surgical drape, reusable, sterile	A sterile protective covering made of natural or synthetic materials, or both, designed to isolate a site of surgical incision or a surgical field from contamination (e.g., microbial, substance) in various clinical settings (e.g., in an operating room or catheterization laboratory). The device may also be used to protect a patient from heat/flame during a surgical procedure. This is a reusable device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10614950000170	GS1	Carton	20	In Commercial Distribution
Primary	00614950000173	GS1

Customer Contacts

• Phone: [phone] ext. 214
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Width	40	Inch
Length	48	Inch