Bone marrow biopsy system

GUDID 04260277173135

Möller Medical GmbH

Bone marrow biopsy needle, single-use
Primary Device ID04260277173135
NIH Device Record Key8e3319c1-8adc-4f66-8511-e39c6f1aa1c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone marrow biopsy system
Version Model NumberBOW-1060-08-0100
Company DUNS320405061
Company NameMöller Medical GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104260277173135 [Primary]
GS104260277173173 [Package]
Package: [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-17
Device Publish Date2018-08-17

On-Brand Devices [Bone marrow biopsy system]

04260277175832BOW-1070-15-0041
04260277173203BOW-1060-11-0150
04260277173197BOW-1060-11-0100
04260277173180BOW-1060-08-0150
04260277173135BOW-1060-08-0100
04260632793367BOW-1066-13-0100
04260632793350BOW-1066-13-0062
04260632793343BOW-1066-11-0150
04260632793336BOW-1066-11-0125
04260632793329BOW-1066-11-0100
04260632793312BOW-1066-08-0150
04260632793305BOW-1066-08-0125
04260632793213BOW-1066-08-0100
04260632793206BOW-1076-15-0100
04260632793190BOW-1076-15-0050

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