Tape,medical,paper,2.5cmx5m,roll,PAC-12

GENERAL DESCRIPTION:
Tape, medical, paper, 2.5cm x 5m, roll, PAC-12

DEFINITION:
Hypoallergenic, lightweight and breathable paper tape is designed to firmly adhere to the skin or dressing materials but can be removed gently without the risk of damaging sensitive skin. Hypoallergenic tape is ideal for infants, the elderly, and for post-surgery application and will provide long-term adhesion. Hypoallergenic tape is latex-free and free of 90 percent of allergens.

TECHNICAL SPECIFICATIONS
Material: hypoallergenic paper.
Width: 2.5cm.
Length: 5m to 10m.
Perforated for easy tearing to desired length.
Hypoallergenic and latex-free for compatibility with sensitive skin.
Breathable to allow air circulation and prevent skin irritation.
Provides reliable fixation of dressings and medical devices.
Can be easily removed without causing skin trauma or discomfort.
Leaves minimal adhesive residue upon removal.
Non sterile
Roll presentation

Shelf-life:
5 Years

Packing
Primary packaging:
Unit of use: One (1) labeled box / PAC containing 12 units of Medical Paper Tape (2.5 cm x 5 m rolls)
Secondary packaging:
120 individual boxes per carton (depending on the supplier).

QUALITY MANAGEMENT SYSTEM 
Manufacturer is certified for ISO 13485 Medical devices / ISO 9001 - Quality management systems - Requirements for regulatory purposes. 
Supplier is certified for ISO 9001 Quality management systems – Requirements. 

MARKET CLEARANCE AND DEVICE CLASSIFICATION 
CE certified under the EU MDR 2017/745 as Class I device / DOC. 

SAFETY AND PRODUCT STANDARDS:
EN ISO 13485: Medical devices — Quality management systems — Requirements for regulatory

ENVIRONMENTAL CONDITIONS 
Storage conditions: 0 - 50°C / 85% RH. 
Operating conditions: 10 - 40°C / 85% RH. 

WEIGHT AND VOLUME (Packaged) 
Weight: gr. 
Volume:  dm³. 

NOMENCLATURE 
GMDN Code: 

COMPONENT OF A KIT:
Yes, S9901050 IEHK 2024,Suppl. Renewable UNIT