Super Sheath CBDE

Basic Information

• Brand Name: Super Sheath CBDE
• Primary DI: 04543527251952
• Version / Model: (CBDE) CI12L25TP0038
• Company Name: TOGO MEDIKIT CO.,LTD.
• Labeler DUNS: 690724240
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-14
• Public Version: 1
• Public Version Date: 2021-05-24
• Public Version Status: New
• Public Device Record Key: 78d8eb3e-5d6c-4d88-87f6-a2a977ba0e8f

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
GBW	CATHETER, PERITONEAL	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61520	Peritoneal drainage catheter	A sterile flexible tube designed for percutaneous insertion into the peritoneal space typically to drain ascites and abdominal abscesses. It may include disposable devices dedicated to catheter introduction, however it does not include any fluid collection bags/containers. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14543527251959	GS1	Box	10	In Commercial Distribution
Primary	04543527251952	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			12Fr Sheath size, 25cm Length.

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store at room temperature, in a dry, dark place.