FDA.reportPublic FDA data

ClearView

Primary DI
4052838015776
Brand
ClearView
Company
Medi-Globe GmbH
Model
CV2722R
Catalog number
CV2722R
Device description
ClearView Endoscopic Ultrasound Needle, EUS-FNA, 22 G, Needle Length 0 - 8.5 cm, Sheath Diameter 2.7 mm, round stylet
Published
2016-09-22
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
FCGBiopsy Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCGBiopsy NeedleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
4052838015776PackageGS15In Commercial Distribution
04052838015769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4052838015776040528380157764052838015776
04052838015769040528380157694052838015769

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound aspiration biopsy procedure kitA collection of sterile devices that includes a biopsy needle and other supplies used to perform an ultrasound-guided aspiration sampling of tissue. The needle tip must provide a clearly visible image during ultrasound imaging. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge22Gauge

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+4980329730sales@medi-globe.de

Regulatory Flags#

DUNS number
318130267
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052838015363OptimizerCAP132CAP1322016-09-22
4052838015370OptimizerCAP132CAP1322016-09-22
04052838011112SonoTip II EBUS FlexGUS-22-18-022GUS-22-18-0222017-01-30
04052838011457SonoTip® EBUS Pro FlexGUS-42-18-022GUS-42-18-0222017-01-30
04052838011471SonoTip® EBUS ProGUS-45-18-022GUS-45-18-0222017-01-30
04052838011495SonoTip® EBUS Pro FlexGUS-46-18-022GUS-46-18-0222017-01-30
04052838009393Injectra, Sclero TipGSN-01-19-180GSN-01-19-1802019-05-15
04052838009430Injectra, Sclero TipGSN-02-23-180GSN-02-23-1802019-05-15
04052838009454Injectra, Sclero TipGSN-02-23-230GSN-02-23-2302019-05-15
04052838009478Injectra, ScleroTipGSN-03-19-120GSN-03-19-1202019-05-15
04052838009492Injectra, Sclero TipGSN-03-19-160GSN-03-19-1602019-05-15
04052838009515Injectra, Sclero TipGSN-03-19-180GSN-03-19-1802019-05-15
04052838009539Injectra, Sclero TipGSN-03-19-210GSN-03-19-2102019-05-15
04052838009577Injectra, Sclero TipGSN-04-23-120GSN-04-23-1202019-05-15
04052838009591Injectra, Sclero TipGSN-04-23-160GSN-04-23-1602019-05-15
04052838009614Injectra, Sclero TipGSN-04-23-180GSN-04-23-1802019-05-15
04052838009638Injectra, Sclero TipGSN-04-23-230GSN-04-23-2302019-05-15
04052838009652Injectra, Sclero TipGSN-05-19-180GSN-05-19-1802019-05-15
04052838009676Injectra, Sclero TipGSN-05-19-230GSN-05-19-2302019-05-15
04052838009690Injectra, Sclero TipGSN-06-19-180GSN-06-19-1802019-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800025901601BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08800025901854BEXCORE Breast Biopsy NeedleMedicalPark CO.,LTD.FCG2026-06-01
08033860002398BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
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08033860027179BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860043421BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860043438BIOPSYBELLBIOPSYBELL SRLFCG2023-10-23
08033860002572BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860016272BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
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08033860041847BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041854BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041861BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041878BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041885BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041892BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041908BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041915BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041922BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041939BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041946BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041953BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860041960BIOPSYBELLBIOPSYBELL SRLFCG2023-07-04
08033860001728BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860001742BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860001766BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860002558BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03
08033860017361BIOPSYBELLBIOPSYBELL SRLFCG2023-07-03