Moeller Medical Blue

Basic Information

• Brand Name: Moeller Medical Blue
• Primary DI: 04260277175566
• Version / Model: RBG-1000-10-1000
• Company Name: Möller Medical GmbH
• Labeler DUNS: 320405061
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-17
• Public Version: 4
• Public Version Date: 2022-02-07
• Public Version Status: Update
• Public Device Record Key: 76dc4ae1-6c25-424c-bc09-a47374a3caaa

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
KNW	Instrument, Biopsy	Gastroenterology, Urology	876.1075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
22725	End-cut biopsy gun, reusable	A hand-operated surgical instrument designed for the automatic extraction of a core tissue sample from an anatomic structure of the body (i.e., a biopsy), while causing minimal surrounding tissue damage, for pathological examination/testing. It has a spring-loaded mechanism intended for transcutaneous insertion of its distal needle-like portion. The open cylindrical needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a reusable device intended to be sterilized prior to use.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260277175566	GS1