FDA.reportPublic FDA data

Optimizer

Primary DI
4052838015370
Brand
Optimizer
Company
Medi-Globe GmbH
Model
CAP132
Catalog number
CAP132
Device description
Optimizer™ Polyp Trap, Multi-Chamber Polyp Trap
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
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDQBottle, Collection, Vacuum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
4052838015370PackageGS16In Commercial Distribution
04052838015363PrimaryGS10
04052838015844Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4052838015370040528380153704052838015370
04052838015363040528380153634052838015363
04052838015844040528380158444052838015844

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA cylindrical or bottle-shaped sealable container intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
318130267
Device count
20
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052838015363OptimizerCAP132CAP1322016-09-22
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
04052838009713Injectra, Sclero TipGSN-06-19-230GSN-06-19-2302019-05-15

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