DynaGuard Waterproof Composite Dressing

Basic Information

• Brand Name: DynaGuard Waterproof Composite Dressing
• Primary DI: 00616784303512
• Version / Model: 3035
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-21
• Public Version: 1
• Public Version Date: 2021-06-29
• Public Version Status: New
• Public Device Record Key: ee4c1bb7-22ed-44b1-83e6-3f002dfc13bd

Device Description

DynaGuard Waterproof Composite Dressing, 4"x4"

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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: No
• 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
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	878.4018	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64416	Surgical anti-adhesion material, nonimplantable	A material intended to be placed in the body short term (<= 30 days) to prevent the abnormal fibrous union (adhesion) between one body part/tissue to another, or between one body part/tissue and a dressing, following a surgical procedure. It is made of a single or composite polymer (e.g., hydrogel, silicone) in the form of a barrier membrane or fluid dressing, and may be cut to a desired size/shape. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00616784303529	GS1	Box	10	In Commercial Distribution
Primary	00616784303512	GS1
Package	00616784303536	GS1	Case	12	In Commercial Distribution