BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Cook

DI: 00827002519930 · Model: G51993 · COOK INCORPORATED

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Cook
Primary DI: 00827002519930
Version / Model: G51993
Catalog Number: GDC-1400-53
Company Name: COOK INCORPORATED
Labeler DUNS: 042823948
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-24
Public Version: 4
Public Version Date: 2024-05-01
Public Version Status: Update
Public Device Record Key: a3e48a58-e737-48c3-8c1b-75b3d97f32c5
Distribution End Date: 2024-04-18

Device Description

Gastric Drainage Catheter Set Ultrathane,

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: Yes
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
KNT	TUBES, GASTROINTESTINAL (AND ACCESSORIES)	Gastroenterology, Urology	876.5980	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62391	Non-vascular catheter introduction set	A collection of invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002519930	GS1

Customer Contacts

Phone: +1(812)330-5494
Email: [email protected]

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: Store in dark, dry, cool place.