DANmed

Basic Information

• Brand Name: DANmed
• Primary DI: 04251351116896
• Version / Model: LMZ-121-120
• Catalog Number: LMZ-121-120
• Company Name: DANNORITZER Medizintechnik GmbH & Co. KG
• Labeler DUNS: 314648911
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-06
• Public Version: 4
• Public Version Date: 2022-09-07
• Public Version Status: Update
• Public Device Record Key: 7ca34f49-65b5-4e1e-a57e-6eaa6a68fb5d
• Distribution End Date: 2022-09-06

Device Description

LAP-Insert only, Ø5mm, l=200mm Grasp. forceps MARYLAND, serrated, d/a Tip- length: 13,5mm

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GEI	Electrosurgical, cutting & coagulation & accessories	General, Plastic Surgery	878.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35080	Rigid endoscopic tissue manipulation forceps, reusable	A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251351116896	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K052759	000