Fenestrated Surgical Drape

Basic Information

• Brand Name: Fenestrated Surgical Drape
• Primary DI: 00634916349504
• Version / Model: 96896920
• Catalog Number: 96896920
• Company Name: STANDARD TEXTILE CO., INC.
• Labeler DUNS: 006999858
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 144
• Record Status: Published
• Publish Date: 2018-01-29
• Public Version: 3
• Public Version Date: 2023-07-27
• Public Version Status: Update
• Public Device Record Key: 8b81238a-fb9c-4540-8e0e-88e7e6ebd949

Device Description

Heart Drape, 30 x 34, 1-Ply, Perval Bleach, 10 3/4 x 6 1/2 Rectangular Fenestration, Binding Around Fenestration, Hemmed on All Side

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47780	Patient surgical drape, reusable	A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube). This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00634916349504	GS1
Unit of Use	10634916349501	GS1

Customer Contacts

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