PATIENT KIT, ULT-SHOULDER POSITIONER KIT, 1/EA

Basic Information

• Brand Name: PATIENT KIT, ULT-SHOULDER POSITIONER KIT, 1/EA
• Primary DI: 00842430107337
• Version / Model: 5346-1
• Catalog Number: 5346
• Company Name: MIZUHO ORTHOPEDIC SYSTEMS, INC.
• Labeler DUNS: 084527241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-12-14
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: b09b3713-e57a-4b32-8e19-ed0ab65a7a39

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: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
62619	Surgical linen/cushion set	A collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushions, foam pads, and equipment drapes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10842430107334	GS1	Case	3	In Commercial Distribution
Primary	00842430107337	GS1

Customer Contacts

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