GOBEN

Basic Information

• Brand Name: GOBEN
• Primary DI: 06979032640031
• Version / Model: JD14-R490107
• Company Name: HUZHOU JUNDA INDUSTRY CO., LTD.
• Labeler DUNS: 452976115
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-26
• Public Version: 1
• Public Version Date: 2025-09-03
• Public Version Status: New
• Public Device Record Key: 07244636-3add-49fb-bfc4-6dd6ea331345

Device Description

Closed Wound Drainage System, Silicone Drainage Kit 100ml Bulb Reservoir, Flat Drain 10mm, with Perforation, Sterile

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: Yes
• 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
GBA	Catheter, Balloon Type	General, Plastic Surgery	878.4200	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47035	Polymeric urethral stent, short-term	A sterile non-bioabsorbable tubular device intended for short-term (<= 30 days) introduction into the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder, typically used during the postsurgical healing period [e.g., after thermal treatment of benign prostatic hyperplasia (BPH) or hypospadias/epispadias repair], or to relieve urethral obstruction from BPH and/or detrusor external sphincter dyssynergia (DESD). It is made entirely of a synthetic polymer(s) and may have various designs (e.g., continuous tube, meshed). It may be expandable in situ and disposable devices intended to assist implantation may be 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	06979032640031	GS1
Package	16979032640038	GS1	box	10	In Commercial Distribution
Package	26979032640035	GS1	carton	100	In Commercial Distribution