ReShape Medical™ Guidewire - ReShape Medical™ Guidewire .035” x 260 cm, 13 cm - TECHDEVICE CORPORATION

Duns Number:088189175

Device Description: ReShape Medical™ Guidewire .035” x 260 cm, 13 cm (Straight Tip)

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More Product Details

Catalog Number

RSM300

Brand Name

ReShape Medical™ Guidewire

Version/Model Number

RSM300

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

DQX

Product Code Name

Wire, Guide, Catheter

Device Record Status

Public Device Record Key

98717a7d-165f-46e0-bd34-31081d3a0d05

Public Version Date

June 12, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TECHDEVICE CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1