FDA.reportPublic FDA data

Moeller Medical Blue

Primary DI
04260277175566
Brand
Moeller Medical Blue
Company
Möller Medical GmbH
Model
RBG-1000-10-1000
Published
2018-08-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162588000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162588000Möller Medical Biopsy Needles and SystemsMoller Medical GmbH2017-06-19KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260277175566PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260277175566042602771755664260277175566

GMDN Terms#

Term, Definition table
TermDefinition
End-cut biopsy gun, reusableA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
320405061
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260277172831Breast localisation needleBLM-1110-20-00302018-08-17
04260277172848Breast localisation needleBLM-1110-20-00502018-08-17
04260277172862Breast localisation needleBLM-1110-20-01002018-12-10
04260277172855Breast localisation needleBLM-1110-20-00752018-08-17
04260277172879Breast localisation needleBLM-1110-20-01252018-08-17
04260277172930Breast localisation needleBLM-1120-20-00302018-08-17
04260277172947Breast localisation needleBLM-1120-20-00502018-08-17
04260277172954Breast localisation needleBLM-1120-20-00752018-08-17
04260277172961Breast localisation needleBLM-1120-20-01002018-08-17
04260277172978Breast localisation needleBLM-1120-20-01252018-08-17
04260277173036Breast localisation needleBLM-1130-20-00302018-08-17
04260277173043Breast localisation needleBLM-1130-20-00502018-08-17
04260277173050Breast localisation needleBLM-1130-20-00752018-08-17
04260277173067Breast localisation needleBLM-1130-20-01002018-08-17
04260277173074Breast localisation needleBLM-1130-20-01252018-08-17
04260277173654Breast localisation needleBLM-1125-20-00302018-08-17
04260277173661Breast localisation needleBLM-1125-20-00502018-08-17
04260277173678Breast localisation needleBLM-1125-20-00752018-08-17
04260277173685Breast localisation needleBLM-1125-20-01002018-08-17
04260277173692Breast localisation needleBLM-1125-20-01252018-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450831547Tru-Cut®Merit Medical Systems, Inc.KNW2026-09-29
00888867543904Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543911Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543928Arthrex®ARTHREX, INC.KNW2026-09-25
00888867543935Arthrex®ARTHREX, INC.KNW2026-09-25
08681672056520MaxiCore-M Reusable Automatic Biopsy GunGEOTEK MEDIKAL VE SAGLIK HIZMETLERI TICARET SANAYI LIMITED SIRKETIKNW2026-09-22
00810131882983BMAN BCOR Bone Marrow Aspirate KitSurgentec, LLCKNW2026-08-19
00810131884697BMAN BCOR Bone Marrow Aspirate Kit (with Clip)Surgentec, LLCKNW2026-08-19
00884450476079CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
00884450476093CorVocet™Merit Medical Systems, Inc.KNW2026-08-18
06937278634917CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634924CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634931CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634962CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634979CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634986CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635013CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635020CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635037CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635068CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635075CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635082CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635112CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635129CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635136CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635167CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635174CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635181CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635211CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635228CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15