Harrison

Basic Information

• Brand Name: Harrison
• Primary DI: 00827002167667
• Version / Model: G16766
• Catalog Number: J-HFBS-503540
• Company Name: COOK INCORPORATED
• Labeler DUNS: 042823948
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 7b160f94-c413-4e11-9b10-3b9d30b4530e

Device Description

Harrison Fetal Bladder Stent 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: No
• 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
MPR	Stent,bladder,fetal	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
62396	Foetal bladder shunt	A sterile non-bioabsorbable tubular device intended to be implanted in the bladder of a foetus with post-vesicular obstructive uropathy, to decompress the urinary tract by providing a temporary drainage route for urine from the bladder into the amniotic sac, until the defect can be surgically repaired after birth. It is made of synthetic polymer materials and is typically designed with retention features (e.g., double pigtail). It is inserted through the maternal abdominal wall via a percutaneous suprapubic access tract, under ultrasound guidance; disposable devices to assist implantation are typically included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00827002167667	GS1

Customer Contacts

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

Storage Conditions

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