Orbit-Snare - Orbit-Snare, Rotatable Polypectomy Snare - Medi-Globe GmbH

Duns Number:318130267

Device Description: Orbit-Snare, Rotatable Polypectomy Snare Hexagonal, Loop Diameter 25 mm, Catheter Diameter Orbit-Snare, Rotatable Polypectomy Snare Hexagonal, Loop Diameter 25 mm, Catheter Diameter 2.5 mm, Sheath Length 230 cm

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More Product Details

Catalog Number

02-25-230

Brand Name

Orbit-Snare

Version/Model Number

02-25-230

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FDI

Product Code Name

Snare, Flexible

Device Record Status

Public Device Record Key

157871a4-a598-4b5e-8469-464b998f289a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Additional Identifiers

Package DI Number

4052838015455

Quantity per Package

10

Contains DI Package

04052838015448

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"MEDI-GLOBE GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 51