Guide Wire - Guide Wire, Steel, D=2.5mm, L=160mm, TR, RD - I.T.S. GmbH

Duns Number:303456917

Device Description: Guide Wire, Steel, D=2.5mm, L=160mm, TR, RD

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More Product Details

Catalog Number

35254-160

Brand Name

Guide Wire

Version/Model Number

35254-160

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

Prescription Use (Rx)

-

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

LXH

Product Code Name

Orthopedic Manual Surgical Instrument

Device Record Status

Public Device Record Key

437429ba-8e1d-4ce9-8211-ed54bd2b627c

Public Version Date

December 17, 2018

Public Version Number

1

DI Record Publish Date

November 14, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"I.T.S. GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 410
2 A medical device with a moderate to high risk that requires special controls. 1463