FDA.reportPublic FDA data

Injectra, Sclero Tip

Primary DI
04052838009638
Brand
Injectra, Sclero Tip
Company
Medi-Globe GmbH
Model
GSN-04-23-230
Catalog number
GSN-04-23-230
Device description
Injection Needle / Sclerotherapy Needle , 19 Gauge, needle length 6 mm, tube diameter 2.3 mm, working length 230 cm
Published
2019-05-15
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
FBKEndoscopic Injection Needle, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052838009645PackageGS110In Commercial Distribution
04052838009638PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052838009645040528380096454052838009645
04052838009638040528380096384052838009638

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge19Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep dry, keep away from sunlight

Contacts#

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

Regulatory Flags#

DUNS number
318130267
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
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
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
04052838009713Injectra, Sclero TipGSN-06-19-230GSN-06-19-2302019-05-15

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