Halo - 1.5 Fr, 120 cm, NiTi Tipless Stone Basket - SACRED HEART MEDICAL,INC.

Duns Number:832763002

Device Description: 1.5 Fr, 120 cm, NiTi Tipless Stone Basket

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More Product Details

Catalog Number

554120

Brand Name

Halo

Version/Model Number

554120

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

FFL

Product Code Name

Dislodger, Stone, Basket, Ureteral, Metal

Device Record Status

Public Device Record Key

0d262d7f-8aaf-403c-bd46-d81a18f1d160

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 15, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SACRED HEART MEDICAL,INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10