TIELLE® MAX

Basic Information

• Brand Name: TIELLE® MAX
• Primary DI: 15051978001317
• Version / Model: MTP705
• Catalog Number: MTP705
• Company Name: SYSTAGENIX WOUND MANAGEMENT, LIMITED
• Labeler DUNS: 211352227
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-24
• Public Version: 5
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: 51265180-f5ab-4b75-850e-c93eea6b1f86
• Distribution End Date: 2021-02-28

Device Description

Hydropolymer Non-Adhesive Dressing

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: 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	878.4020	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44970	Exudate-absorbent dressing, non-gel, non-antimicrobial	A wound covering intended to assist in wound healing by absorbing exudate in wounds (e.g., ulcers, burns, surgical wounds, lacerations, abrasions) and often by creating a moist wound-healing environment. It is not in the form of a gel and does not produce a water-absorbent gel upon contact with wound exudates, but may be designed to absorb and remove exudates (e.g., by capillary action); it does not contain an antimicrobial agent, but may include antioxidant properties. The device is available in a variety of forms (e.g., flat sheet/film-like, impregnated pouches, filled sachets, lyophilized matrix, ribbon, rope, foam, liquid, or powder). After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	25051978001314	GS1		10	Not in Commercial Distribution	2021-02-28
Primary	15051978001317	GS1

Device Sizes

Type	Value	Unit	Text
Width	15	Centimeter
Length	15	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 25 Degrees Celsius