NA

Basic Information

• Brand Name: NA
• Primary DI: 07613327115956
• Version / Model: 0913197000
• Catalog Number: 0913197000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: 7c54f4ec-951c-460c-aac0-4236caec9865
• Distribution End Date: 2016-09-23

Device Description

Flashback 1 piece

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
DYB	INTRODUCER, CATHETER	Cardiovascular	870.1340	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35886	Body aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613327115957	GS1	pack	20	Not in Commercial Distribution	2016-09-23
Primary	07613327115956	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	7.0	Centimeter
Needle Gauge	19.0	Gauge