ORTHOVAC

Basic Information

• Brand Name: ORTHOVAC
• Primary DI: 20653405986307
• Version / Model: 0035001
• Catalog Number: 0035001
• Company Name: Conmed Corporation
• Labeler DUNS: 071595540
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2018-10-31
• Public Version: 4
• Public Version Date: 2021-05-25
• Public Version Status: Update
• Public Device Record Key: f5f83986-a84f-46cd-b50e-d957c750d2b6
• Distribution End Date: 2021-05-24

Device Description

Orthopedic Yankauer Kit, Straight, US

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GCX	APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED	General Hospital	880.6740	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35917	Surgical/emergency suction cannula, non-illuminating, single-use	An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30653405986304	GS1	BOX	10	Not in Commercial Distribution	2021-05-24
Primary	20653405986307	GS1
Unit of Use	00653405986303	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			11/32 IN. (9MM) X 12 FT. (3.7 M)

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 50 – 90 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 10 – 32 Degrees Celsius