3M™ Tegaderm™

Basic Information

• Brand Name: 3M™ Tegaderm™
• Primary DI: 08711428085112
• Version / Model: 5643
• Catalog Number: 5643
• Company Name: 3M COMPANY
• Labeler DUNS: 830016148
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-09-24
• Public Version: 2
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: cb6d0f82-163e-4f17-b733-6fc4490f306b

Device Description

3M™ Tegaderm™ Contact Non-Adherent Layer 10 Bags/Carton 4 Cartons/Case 5643

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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
46855	Wound-nonadherent dressing, permeable, non-antimicrobial	A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50707387566260	GS1	BOX	4	In Commercial Distribution
Primary	08711428085112	GS1
Unit of Use	00707387566265	GS1

Customer Contacts

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