Dale Post Surgical Bra

Basic Information

• Brand Name: Dale Post Surgical Bra
• Primary DI: 00817612020490
• Version / Model: 706
• Catalog Number: 706
• Company Name: DALE MEDICAL PRODUCTS, INC.
• Labeler DUNS: 001061233
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-24
• Public Version: 4
• Public Version Date: 2020-06-19
• Public Version Status: Update
• Public Device Record Key: 2d84b1fe-98ba-49f0-b070-8f548ba4751a

Device Description

Dale Post Surgical Bra, XXX-Large, fits E-I, 54"-60", 1 per box.

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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HEF	Binder, Breast	General Hospital	880.5160	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
Previous	H84107061	HIBCC
Primary	00817612020490	GS1

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Cool Dry Place