Dornier MedTech - Nitinol Stone Retrieval Basket 2.2Fr, 120cm, - DORNIER MEDTECH AMERICA, INC.

Duns Number:130789944

Device Description: Nitinol Stone Retrieval Basket 2.2Fr, 120cm, Tipless

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More Product Details

Catalog Number

BEZ22120

Brand Name

Dornier MedTech

Version/Model Number

2.2Fr x 120cm, Tipless Basket

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)

-

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

FGO

Product Code Name

Dislodger, Stone, Flexible

Device Record Status

Public Device Record Key

9442d27e-908a-4957-a7cf-775f3569a047

Public Version Date

February 26, 2020

Public Version Number

1

DI Record Publish Date

February 18, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DORNIER MEDTECH AMERICA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 101