N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00889024367289
• Version / Model: 00-0032-015-00
• Catalog Number: 00-0032-015-00
• Company Name: SYNVASIVE TECHNOLOGY, INC.
• Labeler DUNS: 618258974
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-23
• Public Version: 1
• Public Version Date: 2020-10-01
• Public Version Status: New
• Public Device Record Key: 395a82d8-3f25-4631-82b6-9ff7b94ebbe0

Device Description

Full Length Sling

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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: Yes
• 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
HST	Apparatus, Traction, Non-Powered	Orthopedic	888.5850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13624	Leg sling	A collection of non-sterile bands/straps typically suspended from the user's waist and neck/shoulder, and terminating around an injured leg, intended to support and immobilize the leg during the healing process. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889024367289	GS1

Customer Contacts

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