Shoulder Brace with Airplane Kit

Basic Information

• Brand Name: Shoulder Brace with Airplane Kit
• Primary DI: 00810113683027
• Version / Model: OSAK3
• Catalog Number: OSAK3
• Company Name: Manamed, Inc.
• Labeler DUNS: 084042331
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-09-19
• Public Version: 1
• Public Version Date: 2025-09-29
• Public Version Status: New
• Public Device Record Key: ebff9f82-3a8b-4fd9-9874-e49d974f1c65

Device Description

The Shoulder Brace with Airplane Kit provides support for shoulder surgeries in a universal multiple configuration brace. Suitable for all shoulder surgeries as well as conservative care of shoulder injuries. The Shoulder Brace with Airplane Kit is your new go to shoulder brace for all your clinical needs. Sized universal Low-profile design True Airplane or Gunslinger alignment Two step application Multiple abduction angles Extreme external rotation

Device Characteristics

• Single Use: No
• 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: 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
ILI	Sling, Arm	Physical Medicine	890.3640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12101	Shoulder immobilizer/orthosis, reusable	A prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810113683027	GS1

Customer Contacts

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