H-E-B

Basic Information

• Brand Name: H-E-B
• Primary DI: 00041220819324
• Version / Model: 041220819324
• Company Name: H. E. BUTT GROCERY COMPANY
• Labeler DUNS: 007924756
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2020-07-27
• Public Version: 1
• Public Version Date: 2020-08-04
• Public Version Status: New
• Public Device Record Key: 7e52e538-5c63-4c82-8596-25b83d2df615

Device Description

Butterfly Closures, Wound Closure Strips, 3/8 IN x 1 3/4 IN (0.9 cm x 4.4 cm)

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34865	Butterfly skin-closure adhesive strip	A small, narrow piece of flexible material covered on one side with a pressure-sensitive adhesive, and with broad, wing-shaped ends that function to approximate the edges of a superficial wound. The device may be hypoallergenic and/or waterproof. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20041220819328	GS1	case	72	In Commercial Distribution
Primary	00041220819324	GS1
Unit of Use	60041220819326	GS1