6-Wire Halo 556160

GUDID B0325561600

1.5 Fr, 120 cm, 6-Wire NiTi Tipless Stone Basket

SACRED HEART MEDICAL,INC.

Urinary stone retrieval basket, single-use
Primary Device IDB0325561600
NIH Device Record Key319671f0-a08c-45ba-97c8-5dc8fbd234be
Commercial Distribution StatusIn Commercial Distribution
Brand Name6-Wire Halo
Version Model Number556160
Catalog Number556160
Company DUNS832763002
Company NameSACRED HEART MEDICAL,INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB0325561600 [Primary]

FDA Product Code

FFLDislodger, Stone, Basket, Ureteral, Metal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-11-15

Devices Manufactured by SACRED HEART MEDICAL,INC.

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B0325305200 - Hercules2018-03-29 3.0 Fr, 120 cm, Stainless Steel Paired Wire Helical Stone Basket
B0325305250 - Hercules2018-03-29 3.0 Fr, 120 cm, Stainless Steel Paired Wire Helical Stone Basket with Filiform Tip
B0325443100 - Apex2018-03-29 2.4 Fr, 90 cm, NiTi Flat Wire Stone Basket
B0325443200 - Apex2018-03-29 2.4 Fr, 120 cm, NiTi Flat Wire Stone Basket
B0325503100 - Vantage2018-03-29 2.4 Fr, 90 cm, NiTi Tipless Stone Basket
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