NA

Basic Information

• Brand Name: NA
• Primary DI: 04546540467164
• Version / Model: 5400031052
• Catalog Number: 5400-031-052
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-23
• Public Version: 4
• Public Version Date: 2022-01-17
• Public Version Status: Update
• Public Device Record Key: 5de27e07-fbb1-4080-8a7f-00f2c155510b

Device Description

Intra-Oral Blade (5.0 x 0.38 x 12.0mm)

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: 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: 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
GFA	BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL	General, Plastic Surgery	878.4820	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43376	Surgical saw blade, sagittal, single-use	A flat surgical cutting instrument, usually made of high-grade stainless steel, with a serrated edge designed for attachment to a dedicated powered saw used for cutting bone/tissue during orthopaedic or oral surgery; it is not dedicated to cutting through the sternum (i.e., not a sternum saw blade). This device is designed with the cutting teeth arranged in an arc or on a flat plane pointing directly forward at the distal end to cut in a rapid sagittal (side to side) motion; it may in addition cut in an oscillating motion. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04546540467164	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Material Thickness: 0.38 Millimeter
Device Size Text, specify			Cut Edge: 5.0 Millimeter
Depth	12.0	Millimeter
Device Size Text, specify			Cut Thickness: 0.51 Millimeter