Syvek Brace with Straps

Basic Information

• Brand Name: Syvek Brace with Straps
• Primary DI: 00389142000032
• Version / Model: 420-05
• Company Name: MARINE POLYMER TECHNOLOGIES, INC.
• Labeler DUNS: 809739386
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-22
• Public Version: 1
• Public Version Date: 2020-10-30
• Public Version Status: New
• Public Device Record Key: 05569042-fab1-4fd7-971b-735dbb84454e

Device Description

Syvek Brace with Straps

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: 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
CCX	Support, Patient Position	Anesthesiology	868.6820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45128	Wrist immobilizer, single-use	A rigid support designed to temporarily render the wrist immovable (i.e., prevention of flexion, extension, and rotation) as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist and/or to prevent injury during a procedure (e.g., radial catheterization). The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10389142000039	GS1	Box	20	In Commercial Distribution
Primary	00389142000032	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]