Sterion®Clamp Cover Fabric

Basic Information

• Brand Name: Sterion®Clamp Cover Fabric
• Primary DI: 00887761000445
• Version / Model: 071001PBX
• Company Name: ASPEN SURGICAL PRODUCTS, INC.
• Labeler DUNS: 027680821
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2018-12-13
• Public Version: 5
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: ca387c8b-c9bb-4ff3-ad34-56a0302dcad4
• Distribution End Date: 2022-04-01

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	10887761000442	GS1		10	Not in Commercial Distribution	2022-04-01
Primary	00887761000445	GS1
Unit of Use	80887761000441	GS1

Customer Contacts

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