PEMIDrape - C-arm sterile cover set, metal temple cover blue line, Art.Nr. SP-CA

Basic Information

• Brand Name: PEMIDrape - C-arm sterile cover set, metal temple cover blue line, Art.Nr. SP-CA
• Primary DI: 04260462742528
• Version / Model: SP-CA-3
• Catalog Number: SP-CA-3
• Company Name: Pemax Kunststoff GmbH
• Labeler DUNS: 341672714
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2024-06-05
• Public Version: 3
• Public Version Date: 2024-09-11
• Public Version Status: Update
• Public Device Record Key: d8117fbd-f74e-4152-a33f-5bc0904f864e

Device Description

PEMIDrape - C-arm sterile cover set, metal temple cover blue line, Art.Nr. SP-CA-3

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: Yes
• 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
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
12535	Medical equipment/instrument drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04260462742542	GS1	Box	4	In Commercial Distribution
Primary	04260462742528	GS1
Unit of Use	04260462742535	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 35 Degrees Celsius