N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00885825017347
• Version / Model: N/A
• Catalog Number: HAR36
• Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.
• Labeler DUNS: 020198912
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 7
• Public Version Date: 2023-09-25
• Public Version Status: Update
• Public Device Record Key: f65b45c8-ef7c-45d8-96c0-f74d1cea3e25
• Distribution End Date: 2023-09-24

Device Description

Ultrasonic Scalpel Shears without Adaptive Tissue Technology

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: No
• 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
NLQ	Scalpel, ultrasonic, reprocessed	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
61845	Soft-tissue ultrasonic surgical system holder/tip, reprocessed	A hand-held component of an ultrasonic surgical system which includes a holder with controls and a surgical endpiece (tip) intended to be connected to a system transducer (not included) whereby the tip oscillates (vibrates) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. It may be referred to as a handpiece but does not include a transducer; the tip is available in a variety of forms and sizes, and is typically made of metal. This device is utilized in a variety of surgical disciplines. This is a previously used single-use device that has been processed for an additional single-use patient application.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30885825017348	GS1	pack	6	Not in Commercial Distribution	2023-09-24
Primary	00885825017347	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K133672	000

Device Sizes

Type	Value	Unit	Text
Length	36.0	Centimeter
Device Size Text, specify			Diameter: 5.5 Millimeter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius