Stone basket

GUDID 04059082026084

SOPRO-COMEG GmbH

Bone punch, reusable
Primary Device ID04059082026084
NIH Device Record Keyac1ccd64-fbb4-4eb6-b845-3b969b3c76f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameStone basket
Version Model Number395 400 100
Company DUNS507185952
Company NameSOPRO-COMEG GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104059082026084 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FFLDislodger, Stone, Basket, Ureteral, Metal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082026084]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-12

On-Brand Devices [Stone basket]

04059082031866395 400 101
04059082031859395 400 100
04059082026091395 400 101
04059082026084395 400 100

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