Steelex - STEELEX MONOFIL 5 (7) 6X45CM LP - B BRAUN SURGICAL SA

Duns Number:511268005

Device Description: STEELEX MONOFIL 5 (7) 6X45CM LP

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More Product Details

Catalog Number

G0098515

Brand Name

Steelex

Version/Model Number

G0098515

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

GAQ

Product Code Name

SUTURE, NONABSORBABLE, STEEL, MONOFILAMENT AND MULTIFILAMENT, STERILE

Device Record Status

Public Device Record Key

c188cc76-0ea8-4b3d-ae4d-df204d6791f7

Public Version Date

October 14, 2021

Public Version Number

7

DI Record Publish Date

August 19, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B BRAUN SURGICAL SA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 13