SURJEX

Basic Information

• Brand Name: SURJEX
• Primary DI: G383HARTMANNHAEMOSTA7
• Version / Model: WM3197440-WM3197441
• Catalog Number: WM3197440-WM3197441
• Company Name: SURJEX
• Labeler DUNS: 645518882
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-31
• Public Version: 1
• Public Version Date: 2024-04-08
• Public Version Status: New
• Public Device Record Key: 650d0f4f-1343-4e4a-b217-66792480ba2c

Device Description

Hartmann Haemostatic-Mosquito 4" 10cm Straight Hemo Hatmann CVD 4" 10cm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEN	Forceps, General & Plastic Surgery	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42468	Clamp manipulation forceps	A hand-held manual surgical instrument with a dedicated, slotted, working end that is designed to accept, grasp, open, apply and remove small types of bulldog/vascular clamps. It is typically made of high-grade stainless steel with jaws at the working end designed to accept the clamp; this gives the surgeon greater range of use of the bulldog clamp into the wound. It has typically a straight design with a slightly curved geometry toward the working end. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G383HARTMANNHAEMOSTA7	HIBCC