FDA.reportPublic FDA data

Click-Tip

Primary DI
4052838015653
Brand
Click-Tip
Company
Medi-Globe GmbH
Model
05-19-230
Catalog number
05-19-230
Device description
Click-Tip Injection Needle, 25 G, Needle Length 4 mm, Catheter Diameter 1.9 mm, Sheath Length 230 cm
Published
2016-09-21
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
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
4052838015653PackageGS110In Commercial Distribution
04052838015646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4052838015653040528380156534052838015653
04052838015646040528380156464052838015646

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and avoid exposure to sunlight and chemical fumes
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

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
true
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

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