FDA.reportPublic FDA data

SOMATEX

Primary DI
08033860021603
Brand
SOMATEX
Company
BIOPSYBELL SRL
Model
SOMACORE VERIFY
Catalog number
900380-US
Published
2016-08-01
Public version status
Update
Distribution status
Not 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
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
08033860021603PackageGS15Not in Commercial Distribution
08033860021597PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033860021603080338600216038033860021603
08033860021597080338600215978033860021597

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy procedure kit, non-medicatedA collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Needle Gauge14Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+39053527850medical@biopsybell.it

Regulatory Flags#

DUNS number
438746708
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
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
08033860021627SOMATEXSOMACORE VERIFY900382-US2016-08-01
08033860021641SOMATEXSOMACORE VERIFY900390-US2016-08-01
08033860021665SOMATEXSOMACORE VERIFY900392-US2016-08-01
08033860021689SOMATEXSOMACORE VERIFY900400-US2016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
06937278635983CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636003CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636010CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636027CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636034CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636041CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636058CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636065CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636072CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636089CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636096CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636102CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636119CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636126CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636133CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636140CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636157CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636164CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636171CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636188CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636195CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636201CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636218CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636225CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636232CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636249CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636256CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31