Trulife

Basic Information

• Brand Name: Trulife
• Primary DI: 00645517879567
• Version / Model: W4040DD38
• Company Name: Trulife Limited
• Labeler DUNS: 201789518
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-31
• Public Version: 1
• Public Version Date: 2023-01-09
• Public Version Status: New
• Public Device Record Key: cd3c7e2b-fdb2-40c4-9c73-ad75be91f9c6

Device Description

HARPER WHITE SEAMLESS SMOOTH SOFTCUP MASTECTOMY BRA W4040DD38

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: 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NOK	MATERIAL, EXTERNAL AESTHETIC RESTORATION, NO ADHESIVE	General, Plastic Surgery	878.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
10481	Postsurgical brassiere, non-antimicrobial	A woman's undergarment designed to support and/or contour the breast(s) after surgical intervention (e.g., thoracic surgery, mastectomy, lumpectomy); it may also be intended for use during medical treatment (e.g., chemotherapy). It may also be referred to as bra, and is specifically designed for patient support/comfort in the home or healthcare facility; it does not include antimicrobial features. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00645517879567	GS1