FDA.reportPublic FDA data

Orbit-Snare

Primary DI
04052838015387
Brand
Orbit-Snare
Company
Medi-Globe GmbH
Model
01-15-230
Catalog number
01-15-230
Device description
Orbit-Snare, Rotatable Polypectomy Snare Oval, Loop Diameter 15 mm, Catheter Diameter 2.5 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
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDISnare, Flexible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
4052838015394PackageGS110In Commercial Distribution
04052838015387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
4052838015394040528380153944052838015394
04052838015387040528380153874052838015387

GMDN Terms#

Term, Definition table
TermDefinition
Flexible polypectomy snare, single-useA flexible device intended to be inserted through an endoscope to ligate, cauterize, and cut polyps, or other mucosal lesions in the gastrointestinal (GI) tract, using high frequency current. It typically consists of a flexible insulated insertion sheath, a snare loop attached to the distal end of the sheath, and an operating wire connected to both the loop and a handle which controls the operating wire. The proximal end of the operating wire is connected to a high frequency power supply unit. 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@med-globe.de

Regulatory Flags#

DUNS number
318130267
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052838002417Endoflux™GBS-01-07-0052026-08-27
04052838002424Endoflux™GBS-01-07-005S2026-08-27
04052838002431Endoflux™GBS-01-07-0062026-08-27
04052838002448Endoflux™GBS-01-07-0072026-08-27
04052838002455Endoflux™GBS-01-07-007S2026-08-27
04052838002462Endoflux™GBS-01-07-0092026-08-27
04052838002479Endoflux™GBS-01-07-009S2026-08-27
04052838002486Endoflux™GBS-01-07-0102026-08-27
04052838002493Endoflux™GBS-01-07-0112026-08-27
04052838002509Endoflux™GBS-01-07-0122026-08-27
04052838002516Endoflux™GBS-01-07-012S2026-08-27
04052838002523Endoflux™GBS-01-07-0142026-08-27
04052838002530Endoflux™GBS-01-07-0152026-08-27
04052838002547Endoflux™GBS-01-07-015S2026-08-27
04052838002554Endoflux™GBS-01-07-0162026-08-27
04052838002561Endoflux™GBS-01-08-0042026-08-27
04052838002578Endoflux™GBS-01-08-0052026-08-27
04052838002585Endoflux™GBS-01-08-005S2026-08-27
04052838002592Endoflux™GBS-01-08-0062026-08-27
04052838002608Endoflux™GBS-01-08-0072026-08-27

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Primary DI, Brand, Company table
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00724995194369CoinTipUS EndoscopyFDI2020-06-11
00724995194376CoinTipUS EndoscopyFDI2020-06-11
00724995194383CoinTipUS EndoscopyFDI2020-06-11
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00724995182908Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182915Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182922Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995182939Roth Net PlatinumUS EndoscopyFDI2020-04-02
00724995180782iSnareUS EndoscopyFDI2020-03-19
00724995180799iSnareUS EndoscopyFDI2020-03-19
00724995180805iSnareUS EndoscopyFDI2020-03-19
00724995180812iSnareUS EndoscopyFDI2020-03-19
00724995180829iSnareUS EndoscopyFDI2020-03-19
00724995182472Short ThrowUS EndoscopyFDI2020-03-19
00724995182489Short ThrowUS EndoscopyFDI2020-03-19
00724995182496Roth NetUS EndoscopyFDI2020-03-19
00724995182502Roth NetUS EndoscopyFDI2020-03-19
00724995182519Roth NetUS EndoscopyFDI2020-03-19
00724995182526Roth NetUS EndoscopyFDI2020-03-19
00724995182533Roth NetUS EndoscopyFDI2020-03-19
00724995182540Polyp PakUS EndoscopyFDI2020-03-19
00724995182571LariatUS EndoscopyFDI2020-03-19
00724995182588LariatUS EndoscopyFDI2020-03-19
00724995182595Short ThrowUS EndoscopyFDI2020-03-19
00724995182601TraxtionUS EndoscopyFDI2020-03-19
00724995182625HistolockUS EndoscopyFDI2020-03-19