NA

Basic Information

• Brand Name: NA
• Primary DI: 04546540184795
• Version / Model: 0212011000
• Catalog Number: 0212-011-000
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-24
• Public Version: 4
• Public Version Date: 2020-02-19
• Public Version Status: Update
• Public Device Record Key: c352ae12-e8c3-4d87-916b-7cf0f016d6f9
• Distribution End Date: 2019-03-31

Device Description

3/4 Perforation Flat Silicone Wound Drain

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
CAC	APPARATUS, AUTOTRANSFUSION	Anesthesiology	868.5830	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47977	Whole-blood-recovery autotransfusion system, powered	An assembly of devices used to collect, filter, and reinfuse intraoperative and/or postoperative autologous blood shed during and/or after elective and non-elective surgery. It is a complete, closed-circuit system that typically includes a suction set or a catheter for blood access, a collection unit, an autotransfusion bag, safety clamps, non-return valves, various blood screening filters, and a transfusion set. The suction mechanism is typically actuated by a central vacuum system. A trocar may also be included. The device is typically used when there is a lack of donor blood or when compatible blood is not available. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	34546540184796	GS1	pack	10	Not in Commercial Distribution	2019-03-31
Primary	04546540184795	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Width	10.0	Millimeter