FDA.reportPublic FDA data

BIOPSYBELL

Primary DI
08033860041892
Brand
BIOPSYBELL
Company
BIOPSYBELL SRL
Model
ILIAC MARROW EXPLANT
Catalog number
IME1312
Device description
Needle for bone-marrow explant
Published
2023-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FCGBiopsy Needle
KNWInstrument, Biopsy

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130616000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130616000MANUAL-BONE-MARROW-BIOPSY-NEEDLES, SEMI-AUTOMATIC-BIOPSY-NEEDLES, AUTOMATIC-BIOPSY-NEEDLESBiopsybell S.R.L.2014-02-07KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033860041892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033860041892080338600418928033860041892

GMDN Terms#

Term, Definition table
TermDefinition
Bone marrow explant needleA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously explant bone marrow (explant is the collection and transfer of living bone marrow from its natural site to a new site, or to a culture medium). The device is typically available in a variety of large bores, and is sufficiently robust to penetrate bone (usually the sternum, hip bone, or posterior iliac crest) with the force of pressure and twisting manually applied to its proximal handgrip. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length120Millimeter
Needle Gauge13Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39 053527850support@biopsybell.it

Regulatory Flags#

DUNS number
438746708
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033860047832BIOPSYBELLBONE ACCESS NEEDLEBAN1120CDT-EM2026-07-08
08033860002008BIOPSYBELLUNLUX SYSTEMULSEC1115C2021-03-12
08033860046613BIOPSYBELLRENOVA SPINE KYPHOPLASTY TOOL KITRESFAST11-0032025-10-27
08033860021597SOMATEXSOMACORE VERIFY900380-US2016-08-01
08033860021610SOMATEXSOMACORE VERIFY900382-US2016-08-01
08033860021634SOMATEXSOMACORE VERIFY900390-US2016-08-01
08033860021658SOMATEXSOMACORE VERIFY900392-US2016-08-01
08033860021672SOMATEXSOMACORE VERIFY900400-US2016-08-01
08033860021696SOMATEXSOMACORE VERIFY900402-US2016-08-01
08033860021719SOMATEXSOMACORE VERIFY900404-US2016-08-01
08033860021733SOMATEXSOMACORE VERIFY900410-US2016-08-01
08033860021757SOMATEXSOMACORE VERIFY900412-US2016-08-01
08033860021771SOMATEXSOMACORE VERIFY S900480-US2016-08-01
08033860021795SOMATEXSOMACORE VERIFY S900490-US2016-08-01
08033860021818SOMATEXSOMACORE VERIFY S900492-US2016-08-01
08033860021832SOMATEXSOMACORE VERIFY S900500-US2016-08-01
08033860021856SOMATEXSOMACORE VERIFY S900502-US2016-08-01
08033860021603SOMATEXSOMACORE VERIFY900380-US2016-08-01
08033860021627SOMATEXSOMACORE VERIFY900382-US2016-08-01
08033860021641SOMATEXSOMACORE VERIFY900390-US2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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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
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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06937278635327CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-15