FDA.reportPublic FDA data

M-Biopsy

Primary DI
05711055002196
Brand
M-Biopsy
Company
Mermaid Medical A/S
Model
N30116008
Catalog number
N30116008
Device description
Disposable spring loaded Semi Automatic Biopsy Instrument used for obtaining percutaneous or surgical histological biopsy samples from soft tissue by
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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
K161409000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161409000M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for SemMermaid Medical A/S2016-08-02KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05711055002196PackageGS110In Commercial Distribution
15711055002193PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05711055002196057110550021965711055002196
1571105500219315711055002193

GMDN Terms#

Term, Definition table
TermDefinition
Side-notch biopsy gun handpiece/needleA hand-operated, non-electronic, surgical instrument designed for the automatic extraction of a small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It consists of both: 1) a handpiece with a spring-loaded mechanism and release trigger; and 2) a percutaneous, distal, needle-like portion with a side-notch cutter which when activated causes a sharp, sliding cannula to slice a segment of tissue. 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Centimeter
Needle Gauge16Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight and keep dry
Storage Environment Temperature-29 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4547108570customer@mermaidmedical.com

Regulatory Flags#

DUNS number
308951313
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15711055005125Drain-LokA301005122026-07-08
15711055012185Drain-LokA301012182026-07-08
15711055000311M-DrainD13006015D130060152016-09-24
15711055000328M-DrainD13006020D130060202016-09-24
15711055000359M-DrainD13008025D130080252016-09-24
15711055000373M-DrainD13010025D130100252016-09-24
15711055000410M-DrainD14010040D140100402016-09-24
15711055000434M-DrainD14012040D140120402016-09-24
15711055000458M-DrainD14014040D140140402016-09-24
15711055000472M-DrainD14508040D145080402016-09-24
15711055000496M-DrainD14510040D145100402016-09-24
15711055000519M-DrainD14512040D145120402016-09-24
15711055000533M-DrainD14514040D145140402016-09-24
15711055000557M-DrainD10506025D105060252016-09-24
15711055000588M-DrainD10507020D105070202016-09-24
15711055000595M-DrainD10507025D105070252016-09-24
15711055000625M-DrainD10508020D105080202016-09-24
15711055000632M-DrainD10508025D105080252016-09-24
15711055000663M-DrainD10510020D105100202016-09-24
15711055000670M-DrainD10510025D105100252016-09-24

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Primary DI, Brand, Company table
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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
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06937278634931CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
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06937278634979CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278634986CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
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06937278635235CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635266CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635273CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
06937278635280CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15
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