Shroud Kit

Basic Information

• Brand Name: Shroud Kit
• Primary DI: 00616784477121
• Version / Model: 4771
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-01
• Public Version: 1
• Public Version Date: 2021-09-09
• Public Version Status: New
• Public Device Record Key: f2e31c25-671e-401a-a385-fb6c80dad861

Device Description

Shroud Kit that contains (1) CPE Shroud Wrap, (1) PP Chin Binder, (1) Underpad, (3) Toe Tag with 36", (2) Thread 60", Introduction Sheet, Heat-Sealed Polybag

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KME	Bedding, Disposable, Medical	General Hospital	880.6060	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13583	Shroud kit	A collection of items that includes a sheet-like garment and other equipment intended to be used to prepare a corpse for burial. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00616784477138	GS1	Case	50	In Commercial Distribution
Primary	00616784477121	GS1