Sterion®Clamp Cover Fabric

Basic Information

• Brand Name: Sterion®Clamp Cover Fabric
• Primary DI: 00840113205950
• Version / Model: 072002PBX
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Labeler DUNS: 027680821
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-02-25
• Public Version: 3
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: 61dfca7a-0bdf-4d93-b4c3-4486da2aae7e

Device Description

Provides a sterile interface between the operating room surgical lamps (non-sterile) and the Surgeon or Nurse (sterile).

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: Yes
• 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
KDC	INSTRUMENT, SURGICAL, DISPOSABLE	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
15778	Clamp jaw cover	A device used in pairs that are placed/fitted onto the distal working end (the jaws) of a surgical instrument (e.g., vascular clamps, forceps) to improve atraumatic grip and pressure distribution when clamping an artery or a vein. It is typically a long cylindrical polymer tube available in various sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00840113205967	GS1		40	Not in Commercial Distribution	2022-01-07
Primary	00840113205950	GS1

Customer Contacts

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