Dilation set

GUDID 04059082015200

SOPRO-COMEG GmbH

Urethral bougie, reusable
Primary Device ID04059082015200
NIH Device Record Key963fa611-e939-4410-ab38-b4e3ab0cf024
Commercial Distribution StatusIn Commercial Distribution
Brand NameDilation set
Version Model Number392 999 111
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
GS104059082015200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, general & plastic surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[04059082015200]

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 [Dilation set]

04059082033228191 402 257
04059082032320195 800 050
04059082015200392 999 111
04059082015163392 999 100
04059082009667195 800 050BC
04059082007632191 402 257BC

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