Cook

Basic Information

• Brand Name: Cook
• Primary DI: 00827002171190
• Version / Model: G17119
• Catalog Number: J-DCDS-100000
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-10-02
• Public Version: 1
• Public Version Date: 2020-10-12
• Public Version Status: New
• Public Device Record Key: 3b2e2f67-53e3-4419-9f88-3d77948d8d53

Device Description

Disposable Cervical Dilator Set

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
HDQ	DILATOR, CERVICAL, FIXED SIZE	Obstetrics/Gynecology	884.4530	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47978	Foetal membrane manipulator	A sterile device used to atraumatically mechanically push and position an exposed or prolapsed foetal membrane secondary to an incompetent cervix back through the cervical canal and into the uterus to facilitate the surgical placement of a cervical cerclage in order to prolong pregnancy to a successful live delivery. The device consists of a catheter with a tipless inflatable balloon with a through passage allowing the introduction of injected sterile saline and connectors to accommodate inflation of the balloon and the connection of a syringe; the syringe may be included with the device. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002171190	GS1

Customer Contacts

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

Storage Conditions

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